Identity
- Trade Name
- Headless Screw System Instruments FDA UDI
- Generic Name
- Orthopaedic bone pin container FDA UDI
- Device Name
- 2.0mm Guidewire Dispenser (9") FDA UDI
- Model / Reference
- 001-000055 FDA UDI
- Description
- 2.0mm Guidewire Dispenser (9") FDA UDI
Identifiers
- Catalog Number
- 001-000055 FDA UDI
- Primary DI / UDI-DI
- M6950010000550 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic bone pin container FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Headless Screw System Instruments by Tyber Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Tyber Medical
Sources (1)
- FDA UDI 4c48bd6b-e448-4209-ac22-8dc96862bb6a 36 fields · synced Jun 1, 2026