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 row) with automatic grasper. FDA UDI
- Model / Reference
- Complete FIXIT basket 1st row 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 row) with automatic grasper. FDA UDI
Identifiers
- Catalog Number
- EPA9000003 FDA UDI
- Primary DI / UDI-DI
- 03760154003391 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 15d5fc6c-2fb8-45d1-bb91-99e30e08cb91 35 fields · synced May 30, 2026