Identity
- Trade Name
- OSSEOGUARD® FDA UDI
- Generic Name
- Pliable-polymer dental regeneration membrane, non-bioabsorbable FDA UDI
- Device Name
- OSSEOGUARD® PTFE TR150 17 X 25 LARGE FACIAL - 2 UNIT BOX FDA UDI
- Model / Reference
- TR150LF-2 FDA UDI
- Description
- OSSEOGUARD® PTFE TR150 17 X 25 LARGE FACIAL - 2 UNIT BOX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844868041597 FDA UDI
- FDA Product Code
- LYC FDA UDI
- GMDN Term
- Pliable-polymer dental regeneration membrane, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 25 Millimeter FDA UDIWidth — 17 Millimeter FDA UDI
Category: Pliable-polymer dental regeneration membrane, non-bioabsorbable
Osseoguard® by Biomet 3i, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pliable-polymer dental regeneration membrane, non-bioabsorbable.
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- Cytoplast™ Titanium-Reinforced PTFE Membranes — OSTEOGENICS BIOMEDICAL, INC. · Class II
- Cytoplast™ Non-Resorbable PTFE Barrier Membranes — OSTEOGENICS BIOMEDICAL, INC. · Class II
- Cytoplast™ Titanium-Reinforced PTFE Membranes — OSTEOGENICS BIOMEDICAL, INC. · Class II
- Cytoplast™ Titanium-Reinforced PTFE Membranes — OSTEOGENICS BIOMEDICAL, INC. · Class II
- Cytoflex Ti-enforced — UNICARE BIOMEDICAL, INC. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Biomet 3i, Llc
Sources (1)
- FDA UDI b0d1c0d7-03ef-4502-8e6a-baebbf898942 36 fields · synced Jun 8, 2026