Label: KERASORB- amino acids, hair keratin
- NHRIC Code(s): 71474-305-01, 71474-305-05
- Packager: Molecular Biologicals, LLC
- Category: PRESCRIPTION MEDICAL DEVICE LABEL
- DEA Schedule: None
- Marketing Status: Exempt device
Drug Label Information
Updated December 19, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- CAUTION
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DESCRIPTION
Kerasorb® is an advanced bilayer wound care device designed for medium to highly exudative wounds. It is comprised of an absorbent foam with a Keratin (Replicine) wound matrix layer designed for wounds with medium to high exudate. Kerasorb foam wound matrix provides a scaffold for cellular migration, proliferation and capillary growth, while permitting drainage of excess fluids that may accumulate onto the wound bed. It is supplied in single use keratin foam matrix.
- INDICATIONS FOR USE
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DOSAGE & ADMINISTRATION
DIRECTIONS FOR USE (NOTE: ALWAYS HANDLE USING ASEPTIC TECHNIQUE) - WOUND BED PREPARATION & APPLICATION
- 1.
- Prepare wound area using standard debridement methods to ensure the wound is free of debris and devitalized tissue. The wound may be surgically debrided to ensure the wound edges contain viable tissue. A small influx of blood may be permitted into the wound.
- 2.
- Using sterile technique remove Kerasorb foam wound matrix from the pouch.
- 3.
- If necessary cut the Kerasorb foam wound matrix into a piece slightly larger than the outline of the wound area (approximately 1.5cm).
- 4.
- Apply Kerasorb® Foam Wound Matrix into the wound area. Ensure that the keratin matrix layer ("shiny side") makes contact with the wound bed. Secure in place using preferred method by healthcare provider(Steri-strips, sutures, tape). dressing.
- 5.
- After application use an appropriate occlusive
MATRIX CHANGES & REAPPLICATIONS - 6.
- Change kerasorb foam wound matrix as necessary. Frequency of dressing changes typically occur every 5-7 days, or as determined by the healthcare provider.
- 7.
- Once wound is cleansed using proper technique Kerasorb® Foam Wound Matrix may be reapplied.
- 8.
- Proceed with reapplication of appropriate occlusive secondary dressing.
- 9.
- If clinical signs of infection, excessive redness, blistering or suspected allergic reaction occurs the Matrix material should not be reapplied and proper notification and documentation should be done.
- CONTRADICATIONS
- PRECAUTIONS
- STORAGE
- HOW SUPPLIED
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SPL UNCLASSIFIED SECTION
Manufactured for:
Molecular Biologicals, LLC
Pasadena, TX 77505 | 1-844-793-9933
By Keraplast Research, Ltd
Gerald St. Lincoln, 7674 NZKerasorb® is a registered trademark of Molecular Biologicals, LLC.
The product incorporates patented and /or patent pending technologies owned by Molecular Biologicals, LLC.Issue Date 01Jan17
DWG005/9 - PRINCIPAL DISPLAY PANEL - 5 Package Box
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INGREDIENTS AND APPEARANCE
KERASORB
dressing, wound, drugProduct Information Product Type PRESCRIPTION MEDICAL DEVICE Item Code (Source) NHRIC:71474-305 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M) (AMINO ACIDS, HAIR KERATIN - UNII:G46579QK1M) AMINO ACIDS, HAIR KERATIN 100 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:71474-305-01 1 in 1 POUCH 1 1 in 1 PACKAGE; Type 0: Not a Combination Product 2 NHRIC:71474-305-05 5 in 1 BOX 2 5 in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date EXEMPT DEVICE FRO 12/11/2018 Labeler - Molecular Biologicals, LLC (079518915)
