Identity
- Trade Name
- OsteoMed FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Device Name
- Ti ALLOY LONG 4 HOLE BSSO PLATE FDA UDI
- Model / Reference
- 214-1082 FDA UDI
- Description
- Ti ALLOY LONG 4 HOLE BSSO PLATE FDA UDI
Identifiers
- Catalog Number
- 214-1082 FDA UDI
- Primary DI / UDI-DI
- 00842528114346 FDA UDI
- FDA Product Code
- DZL FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4880 FDA UDI
- Commercial Distribution
- 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 1.31 Inch FDA UDI
Category: Craniofacial fixation plate, non-bioabsorbable, non-customized
OsteoMed by Osteomed Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Osteomed Corp.
Sources (1)
- FDA UDI a0f71274-3a5b-4de4-b3a2-63eb9a3b9e00 37 fields · synced May 30, 2026