Identity
- Trade Name
- OsteoMed FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Device Name
- OsteoFlap 17mm Cranial Flap Fixation Device FDA UDI
- Model / Reference
- 218-0061-CH FDA UDI
- Description
- OsteoFlap 17mm Cranial Flap Fixation Device FDA UDI
Identifiers
- Catalog Number
- 218-0061-CH FDA UDI
- Primary DI / UDI-DI
- 00845694004985 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 17 Millimeter 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 2fd68eef-12af-44c8-b1c9-4bf65314fddd 36 fields · synced May 30, 2026