Identity
- Trade Name
- Bariatric Fastclamp EUDAMEDFastClamp - FastClamp System FDA UDI
- Generic Name
- Medical table clamp FDA UDI
- Device Name
- FastClamp EUDAMEDBariatric Fastclamp FDA UDI
- Model / Reference
- A-1001 EUDAMEDFDA UDI
- Description
- Bariatric Fastclamp FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986011530 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051986SIRUF4A EUDAMED
- Direct Marketing DI
- 05051986011530 EUDAMED
- 510(k) Number
- K100442 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L0318 INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE EUDAMED
- GMDN Term
- Medical table clamp FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
No
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
Bariatric Fastclamp by Surgical Innovations Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 5051986SIRUF4A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Surgical Innovations Ltd.
- EUDAMED SRN
- GB-MF-000012187
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (2)
- EUDAMED 923e8bbf-1c2e-45aa-90fd-88c20b747f9e 61 fields · synced Jun 18, 2026
- FDA UDI 8c9c0fc2-0a3c-4621-b333-3e3264d7c349 34 fields · synced May 29, 2026