Label: COLLANEX COLLAGEN PARTICLES- bovine type i collagen powder
- NHRIC Code(s): 58980-754-05
- Packager: STRATUS PHARMACEUTICALS INC
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Premarket Notification
Drug Label Information
Updated November 29, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Product Information
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Product Application
- Cleanse the wound.
- Apply medication to the wound if indicated.
- Apply Collanex™ Particles 1/4 inch thick to the wound surface. Do not pack tightly; allow for expansion of particles.
- Cover with non-stick dressing.
- Use Collanex™ Particles until wound is fully healed.
- Maintain a moist wound environment.
- Product Removal
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Precautions
- Wounds may appear to be larger during the first several days of treatment due to the reduction of swelling.
- An increase in drainage may be seen in the first several days of treatment.
- The product is made from bovine materials. Do not use if you have an allergy to bovine derived materials (milk, beef products, leather, etc.)
- Warnings: Discontinue use of Collanex™ Particles and notify your doctor if excessive redness, pain, swelling or blistering occurs.
- All open and unused portions must be discarded.
- Warnings: Potencial risk of loss of sterility and infection if opened and reused.
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 1 g Vial Carton
COLLANEX™
Collagen Particles
Five Vials, 1g eachCollagen Particles
Triple Helical MatixConforms to FDA Quality System Requirements.
Manufactured as per cGMP standards.
Product Information:
- This device is intended for single use only.
- All open and unused portions must be discarded.
- Sterility guaranteed in unopened, undamaged pack-
age only. - Store in a cool and dry place.
RX Only
Five Vials, 1g each
STRATUS
PHARMACEUTICALS INCReorder 5898075405
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INGREDIENTS AND APPEARANCE
COLLANEX COLLAGEN PARTICLES
dressing, wound, collagen powderProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:58980-754 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOVINE TYPE I COLLAGEN (UNII: FHJ3ATL51C) (BOVINE TYPE I COLLAGEN - UNII:FHJ3ATL51C) BOVINE TYPE I COLLAGEN 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:58980-754-05 5 in 1 BOX 1 1 in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Premarket Notification K910944 05/01/1991 Labeler - STRATUS PHARMACEUTICALS INC (789001641) Establishment Name Address ID/FEI Business Operations Human BioSciences Inc 014511541 MANUFACTURE, LABEL