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FIXIT® Knotless
EUDAMEDFDA UDIClass I (EU MDR)
Ref EPA9000303Model Pin
by S.b.m. Sas
Identity
- Trade Name
- FIXIT® Knotless EUDAMEDFIXIT FDA UDI
- Generic Name
- Wire/ligature passer, reusable FDA UDI
- Device Name
- Suture retriever pin EUDAMEDReusable suture retriever pin, to be used with FIXIT suture anchors for rotator cuff repair. FDA UDI
- Model / Reference
- Pin EUDAMEDEPA9000303 EUDAMEDReusable suture retriever pin FDA UDI
- Description
- Reusable suture retriever pin, to be used with FIXIT suture anchors for rotator cuff repair. FDA UDI
Identifiers
- Catalog Number
- EPA9000303 FDA UDI
- Primary DI / UDI-DI
- 03760154003353 EUDAMEDFDA UDI
- Basic UDI-DI
- 376015400DT2019024VH EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091099 OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Wire/ligature passer, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Category: Surgical implant template, reusable
FIXIT® Knotless by S.b.m. Sas — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376015400DT2019024VH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- S.b.m. Sas
- EUDAMED SRN
- FR-MF-000000214
Sources (2)
- EUDAMED 6182f0c2-0a11-4524-a4ff-a9be8e451f09 61 fields · synced Jun 20, 2026
- FDA UDI 02148413-c312-43a6-b13e-b2d40f6f325b 34 fields · synced May 30, 2026