Identity
- Trade Name
- Celluheal FDA UDI
- Generic Name
- Animal-derived wound matrix dressing FDA UDI
- Device Name
- Cellufil sterile collagen particles, 1 gram pouch FDA UDI
- Model / Reference
- CF2001 FDA UDI
- Description
- Cellufil sterile collagen particles, 1 gram pouch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850048866041 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
No
FDA UDI
Over-the-Counter
Yes
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
Celluheal 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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- Kerecis® GraftGuide® — KERECIS hf. · U
- HealiAid Collagen Wound Dressing — MAXIGEN BIOTECH INC. · U
- Solventum™ Promogran™ — Solventum US LLC · U
- 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 4280298a-072d-4d86-bb59-8a3717725355 34 fields · synced Jun 1, 2026