X-STATIC SILVERSEAL HYDROGEL DRESSING 4 X 5- dressing, wound and burn, hydrogel w/drug and/or biologic    
X-STATIC SILVERSEAL HYDROGEL DRESSING 2 X 3- dressing, wound and burn, hydrogel w/drug and/or biologic    
X-STATIC SILVERSEAL HYDROGEL DRESSING 2 X 2- dressing, wound and burn, hydrogel w/drug and/or biologic    
X-STATIC SILVERSEAL HYDROGEL DRESSING 3- dressing, wound and burn, hydrogel w/drug and/or biologic    
HYDRESS- dressing,wound,hydrophilic    
Alliqua Inc

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HYDROGEL DRESSING

Apply as a single layer.

Overlay with conventional dressings.

SilverSeal® Hydrogel Dressing is intended for the management of wounds and to provide an antimicrobial barrier

Silverseal® Hydrogel is intended for the management of wounds and to provide an antimicrobial barrier

Applicable to:

Partial and full thickness ulcers, leg ulcers (vascular, venous, pressure and diabetic), superficial wounds, abrasions, first and second degree burns, and donor sites.
Silverseal® Hydrogel Dressing contains approximately 1.5% X-Static® silver coated fiber

Antibacterial activity was confirmed via in vitro studies of bacterial growth dressing.

To facilitate removal, moisten with sterile water.

Caution: federal law restricts this device to sale by or on the order at a licensed practitioner.

Use before expiration date.

Principal Display Panel – 2” X 2” Dressing Box Label

SILVER
SEAL®

(00)00000000000000
HYDROGEL DRESSING
NDC 58198-122-10 PRODUCT CODE
AA-000000-000
STERILE Contents: Ten (10) Dressing
SINGLE USE ONLY 2” X 2” (5.1cm X 5.1cm)

Manufactured by Aquamed Technologies Inc.
For Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047
www.Alliqua.com

Principal Display Panel – 2” X 2” Dressing Box Label

Principal Display Panel – 2” X 2” Dressing Pouch Label

SILVER
SEAL®

(00)00000000000000
HYDROGEL DRESSING
NDC 58198-122-01 PRODUCT CODE
AA-000000-000
STERILE Contents: One (1) Dressing
SINGLE USE ONLY 2” X 2” (5.1cm X 5.1cm)

Manufactured by Aquamed Technologies Inc.
For Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047
www.Alliqua.com

Principal Display Panel – 2” X 2” Dressing Pouch Label

Principal Display Panel – 2” X 3” Dressing Box Label

NDC 58198-123-10

SILVER
SEAL®

(01)10816789010027

HYDROGEL DRESSING

PRODUCT CODE
AB-200300-103


STERILE Contents: Ten (10) dressings
SINGLE USE ONLY 2” X 3” (5.1cm X 7.6cm)

Manufactured by Aquamed Technologies Inc.

for Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047

www.Alliqua.com

Principal Display Panel – 2” X 3” Dressing Box Label

Principal Display Panel – 4” X 5” Dressing Box Label

NDC 58198-123-01

SILVER
SEAL®

(01)00816789010020 HYDROGEL DRESSING

PRODUCT CODE
AB-200300-103

STERILE Contents: One (1) dressing
SINGLE USE ONLY 2” X 3” (5.1cm X 7.6cm)

Manufactured by Aquamed Technologies Inc.

for Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047

Principal Display Panel – 4” X 5” Dressing Box Label

Principal Display Panel – 3” Circle Dressing Box Label

SILVER
SEAL®

(00)00000000000000
HYDROGEL DRESSING
NDC 58198-130-10 PRODUCT CODE
AA-000000-000
STERILE Contents: Ten (10) Dressing
SINGLE USE ONLY 3” Circle (7.6cm circle)

Manufactured by Aquamed Technologies Inc.
For Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047
www.Alliqua.com

Principal Display Panel – 3” Circle Dressing Box Label

Principal Display Panel – 3” Circle Dressing Pouch Label

SILVER
SEAL®

(00)00000000000000
HYDROGEL DRESSING
NDC 58198-130-01 PRODUCT CODE
AA-000000-000
STERILE Contents: One (1) Dressing
SINGLE USE ONLY 3” Circle (7.6cm circle)

Manufactured by Aquamed Technologies Inc.
For Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047
www.Alliqua.com

Principal Display Panel – 3” Circle Dressing Pouch Label

Principal Display Panel – 4” X 4" Circle Dressing Box Label

NDC 58198-044-10 PRODUCT CODE

AB-400400-001

HYDRESSTM

(01)10816789010003

HYDROGEL DRESSING
STERILE Contents: Ten (10) Hydrogel Dressings
SINGLE USE ONLY 4” X 4” (10cm X 10cm)

Manufactured by Aquamed Technologies Inc. for Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047 | Tel 855-425-5478 | www.Alliqua.com

Principal Display Panel – 4” X 4" Circle Dressing Box Label

Principal Display Panel – 4” X 4" Circle Dressing Pouch Label

NDC 58198-044-10 PRODUCT CODE

AB-400400-001

HYDRESSTM

(01)00816789010006

HYDROGEL DRESSING
STERILE Contents: One (1) dressing
SINGLE USE ONLY 4” X 4” (10cm X 10cm)

Manufactured by Aquamed Technologies Inc. for Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047 | Tel 855-425-5478 | www.Alliqua.com

Principal Display Panel – 4” X 4" Circle Dressing Pouch Label

Principal Display Panel – 4” X 5” Dressing Box Label

NDC 58198-145-10

SILVER
SEAL®

PRODUCT CODE
AB-400500-105

(01)10816789010010

HYDROGEL DRESSING
STERILE Contents: Ten (10) dressings
SINGLE USE ONLY 4” X 5” (10cm X 12.7cm)

Manufactured by Aquamed Technologies Inc. for Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047 | www.Alliqua.com

Principal Display Panel – 4” X 5” Dressing Box Label

Principal Display Panel – 4” X 5” Dressing Box Label

NDC 58198-145-01

SILVER
SEAL®

PRODUCT CODE
AB-400500-105

(01)00816789010013

HYDROGEL DRESSING
STERILE Contents: One (1) dressing
SINGLE USE ONLY 4” X 5” (10cm X 12.7cm)

Manufactured by Aquamed Technologies Inc. for Alliqua Biomedical Inc.
2150 Cabot Boulevard West, Langhorne, PA 19047 | www.Alliqua.com

Principal Display Panel – 4” X 5” Dressing Box Label
X-STATIC SILVERSEAL HYDROGEL DRESSING 4 X 5 
dressing, wound and burn, hydrogel w/drug and/or biologic
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:58189-145
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:58189-145-1010 in 1 CARTON
1NHRIC:58189-145-011 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Premarket NotificationK04001905/15/2013
X-STATIC SILVERSEAL HYDROGEL DRESSING 2 X 3 
dressing, wound and burn, hydrogel w/drug and/or biologic
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:58189-123
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:58189-123-1010 in 1 CARTON
1NHRIC:58189-123-011 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Premarket NotificationK04001905/15/2013
X-STATIC SILVERSEAL HYDROGEL DRESSING 2 X 2 
dressing, wound and burn, hydrogel w/drug and/or biologic
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:58189-122
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:58189-122-1010 in 1 CARTON
1NHRIC:58189-122-011 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Premarket NotificationK04001906/01/2013
X-STATIC SILVERSEAL HYDROGEL DRESSING 3 
dressing, wound and burn, hydrogel w/drug and/or biologic
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:58189-130
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:58189-130-1010 in 1 CARTON
1NHRIC:58189-130-011 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Premarket NotificationK04001906/01/2013
HYDRESS 
dressing,wound,hydrophilic
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:58189-144
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:58189-144-1010 in 1 CARTON
1NHRIC:58189-144-011 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Exempt DeviceFRO05/15/2013
Labeler - Alliqua Inc (872967679)

Revised: 5/2013
Document Id: 61d15e5a-2b34-4007-8e0e-39256c003499
Set id: 91244d66-ed63-4a70-a1ce-e2b77a6b09e1
Version: 1
Effective Time: 20130507
 
Alliqua Inc