Identity
- Trade Name
- BT LOOP® EUDAMEDPULLUP FDA UDI
- Generic Name
- Wire/ligature passer, reusable FDA UDI
- Device Name
- Suture retriever pin EUDAMEDThe Reusable suture retriever pin is intended to be used with PULLUP and BT LOOP adjustable fixation devices for ACL reconstruction. FDA UDI
- Model / Reference
- Pin EUDAMEDPUL9000303 EUDAMEDReusable suture retriever pin FDA UDI
- Description
- The Reusable suture retriever pin is intended to be used with PULLUP and BT LOOP adjustable fixation devices for ACL reconstruction. FDA UDI
Identifiers
- Catalog Number
- PUL9000303 FDA UDI
- Primary DI / UDI-DI
- 03760154003704 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
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Bt Loop® 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 a5aff72a-5816-499a-a9a7-3dfd0aa6539c 61 fields · synced Jul 29, 2026
- FDA UDI 6a1f5455-a09f-4a45-b2c6-7dbc139451ae 34 fields · synced May 30, 2026