COLLANEX COLLAGEN PARTICLES - dressing, wound, collagen powder 
STRATUS PHARMACEUTICALS INC

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COLLANEX™
Collagen Particles

Five Vials, 1g each

Collagen Particles
Triple Helical Matix

Conforms to FDA Quality System Requirements.

Manufactured as per cGMP standards.

Product Information

Product Application

  1. Cleanse the wound.
  2. Apply medication to the wound if indicated.
  3. Apply Collanex™ Particles 1/4 inch thick to the wound surface. Do not pack tightly; allow for expansion of particles.
  4. Cover with non-stick dressing.
  5. Use Collanex™ Particles until wound is fully healed.
  6. Maintain a moist wound environment.

Product Removal

  1. Change as indicated by the amount of drainage and instructions provided with the absorbent cover dressing.
  2. After removal of the cover dressing, repeat steps under Product Application as needed.

Precautions

RX Only

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186
Made in the USA
800-442-7882

STRATUS
PHARMACEUTICALS INC

Reorder 5898075405

Rev1, 062021

PRINCIPAL DISPLAY PANEL - 1 g Vial Carton

COLLANEX™
Collagen Particles
Five Vials, 1g each

Collagen Particles
Triple Helical Matix

Conforms to FDA Quality System Requirements.

Manufactured as per cGMP standards.

Product Information:

RX Only

Five Vials, 1g each

STRATUS
PHARMACEUTICALS INC

Reorder 5898075405

Principal Display Panel - 1 g Vial Carton
COLLANEX COLLAGEN PARTICLES  
dressing, wound, collagen powder
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:58980-754
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C) (BOVINE TYPE I COLLAGEN - UNII:FHJ3ATL51C) BOVINE TYPE I COLLAGEN1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:58980-754-055 in 1 BOX
11 in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Premarket NotificationK91094405/01/1991
Labeler - STRATUS PHARMACEUTICALS INC (789001641)
Establishment
NameAddressID/FEIBusiness Operations
Human BioSciences Inc014511541MANUFACTURE, LABEL

Revised: 11/2021
Document Id: 550d165a-c73e-4bda-846a-2828fdf8db3c
Set id: 03765b32-4aa9-425a-9cda-7ae089b92c25
Version: 1
Effective Time: 20211129
 
STRATUS PHARMACEUTICALS INC