Identity
- Trade Name
- GEM 21S FDA UDI
- Generic Name
- Periodontal root surface regeneration material FDA UDI
- Device Name
- Growth-factor Enhanced Matrix for Periodontal Regeneration FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- Growth-factor Enhanced Matrix for Periodontal Regeneration FDA UDI
Identifiers
- Primary DI / UDI-DI
- D749210005201812047283 FDA UDI
- GMDN Term
- Periodontal root surface regeneration material FDA UDI
Classification
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Gem 21s by Luitpold Pharmaceuticals, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Luitpold Pharmaceuticals, Inc.
Sources (1)
- FDA UDI a56d2bcb-4a0a-447a-8ef6-bde334ee3958 35 fields · synced Jun 8, 2026