Identity
- Trade Name
- ecoFIX 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 ecoFIX implant for rotator cuff repair (1st and 2nd rows) with automatic grasper. FDA UDI
- Model / Reference
- Complete ecoFIX basket - 1st and 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 ecoFIX implant for rotator cuff repair (1st and 2nd rows) with automatic grasper. FDA UDI
Identifiers
- Catalog Number
- EPA9000008 FDA UDI
- Primary DI / UDI-DI
- 03760304681288 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
ecoFIX 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 9ae75859-af82-470b-b9ca-b397671322ae 35 fields · synced Jun 1, 2026