Identity
- Trade Name
- Medifil FDA UDI
- Generic Name
- Animal-derived wound matrix dressing FDA UDI
- Device Name
- Medifil sterile collagen particles, 1 gram vial FDA UDI
- Model / Reference
- MF2001 FDA UDI
- Description
- Medifil sterile collagen particles, 1 gram vial FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850048866126 FDA UDI
- FDA Product Code
- KOZ FDA UDI
- GMDN Term
- Animal-derived wound matrix dressing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4018 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Animal-derived wound matrix dressing
Medifil by Human Biosciences, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Animal-derived wound matrix dressing.
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- HealiAid Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
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- Simpurity — SAFE N SIMPLE LLC · U
- ProgenaMatrix — Progenacare Global, LLC · U
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Human Biosciences, Inc.
Sources (1)
- FDA UDI 6ff509a0-fa5d-4994-84c6-084faa853e8f 34 fields · synced May 29, 2026