Identity
- Trade Name
- Osteo-Force FDA UDI
- Generic Name
- Non-ISO80369-standardized small-bore linear connector, single-use FDA UDI
- Device Name
- Osteo-Force Connecting Tube FDA UDI
- Model / Reference
- G13345 FDA UDI
- Description
- Osteo-Force Connecting Tube FDA UDI
Identifiers
- Catalog Number
- TCT12.4-30-P-FMRA-HPIS FDA UDI
- Primary DI / UDI-DI
- 00827002133457 FDA UDI
- FDA Product Code
- OAR FDA UDI
- GMDN Term
- Non-ISO80369-standardized small-bore linear connector, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4200 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-ISO80369-standardized small-bore linear connector, single-use
Osteo-Force by Cook Incorporated — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI af2141ce-70e4-4b2f-aea7-c6fd4304fe6a 36 fields · synced Jun 8, 2026