Identity
- Trade Name
- OSTEO-Tape FDA UDI
- Generic Name
- General oral wound dressing, animal-derived FDA UDI
- Device Name
- Dental Wound Dressing FDA UDI
- Model / Reference
- OSTEOTAPE FDA UDI
- Description
- Dental Wound Dressing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850011613129 FDA UDI
- FDA Product Code
- KGN FDA UDI
- GMDN Term
- General oral wound dressing, animal-derived FDA UDI
Classification
- Device Class
- U 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: General oral wound dressing, animal-derived
OSTEO-Tape by Collagen Matrix, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General oral wound dressing, animal-derived.
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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 U | Pending data |
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Manufacturer
- Manufacturer
- Collagen Matrix, Inc.
Sources (1)
- FDA UDI 068a9fc6-63c0-4cd7-b107-0c561424ed4a 34 fields · synced Jun 8, 2026