Identity
- Trade Name
- FIXIT FDA UDI
- Generic Name
- Arthroscopic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the FIXIT implant for rotator cuff repair (1st + 2nd rows) with automatic grasper. FDA UDI
- Model / Reference
- Complete FIXIT basket 1st + 2nd rows with automatic grasper FDA UDI
- Description
- Surgical Instrument Set consisting of reusable surgical instruments intended to be used during arthroscopic implantation of the FIXIT implant for rotator cuff repair (1st + 2nd rows) with automatic grasper. FDA UDI
Identifiers
- Catalog Number
- EPA9000004 FDA UDI
- Primary DI / UDI-DI
- 03760154003513 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Arthroscopic 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Fixit by S.b.m — 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
- S.b.m
Sources (1)
- FDA UDI c7595f81-435e-40de-a116-fc21676e46ca 35 fields · synced May 30, 2026