Identity
- Trade Name
- OsteoMed FDA UDI
- Generic Name
- Implantable craniofacial bone distractor FDA UDI
- Device Name
- Activation Wire, 42mm FDA UDI
- Model / Reference
- 216-0300 FDA UDI
- Description
- Activation Wire, 42mm FDA UDI
Identifiers
- Catalog Number
- 216-0300 FDA UDI
- Primary DI / UDI-DI
- 00845694004404 FDA UDI
- FDA Product Code
- MQN FDA UDI
- GMDN Term
- Implantable craniofacial bone distractor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 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 — 42 Millimeter FDA UDI
Category: Implantable craniofacial bone distractor
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 c13d4270-60df-4b7b-9917-ba928af31c31 37 fields · synced Jun 8, 2026