Identity
- Trade Name
- GPC FDA UDI
- Generic Name
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
- Device Name
- Cannulated Drill Bit 4.5 mm (for 7 mm Screw) FDA UDI
- Model / Reference
- IBSC784.45 FDA UDI
- Description
- Cannulated Drill Bit 4.5 mm (for 7 mm Screw) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08904400201383 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General external orthopaedic fixation system implantation kit, reusable
A comprehensive and detailed description of the GPC Medical Limited External Orthopaedic Fixation System Implantation Kit, including its features, compliance, and regulatory status.
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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
- Gpc Medical, Ltd.
Sources (1)
- FDA UDI abbea2e4-f98c-4acc-85bf-c614b923d9ea 34 fields · synced Jul 3, 2026