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Orthopedic Manual Surgical Instrument
FDA UDIClass I (US FDA UDI)
by Fx Solutions
Identity
- Trade Name
- ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- 40/12 HUMELOCK REVERSED BROACH WITH RADIUS FDA UDI
- Model / Reference
- 906-4010-CM1 FDA UDI
- Description
- 40/12 HUMELOCK REVERSED BROACH WITH RADIUS FDA UDI
Identifiers
- Catalog Number
- 906-4010-CM1 FDA UDI
- Primary DI / UDI-DI
- 03701037317662 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable 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
Orthopedic Manual Surgical Instrument by Fx Solutions — 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
- Fx Solutions
Sources (1)
- FDA UDI dabe6128-fdd5-419f-8e5e-2ca262514a4e 35 fields · synced May 30, 2026