Identity
- Trade Name
- Susol EUDAMEDSusol® Scalpel Handle No.9 (Pack of 10) FDA UDI
- Generic Name
- Scalpel handle, single-use FDA UDI
- Device Name
- Susol® Scalpel Handle No.3 EUDAMED
- Model / Reference
- SS04-0100 EUDAMEDSS04-0106 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060418832445 EUDAMED05060418833763 FDA UDI
- Basic UDI-DI
- 506041883SSPOD6327023 EUDAMED
- Unit of Use DI
- 05060418833763 EUDAMED
- FDA Product Code
- GDZ FDA UDI
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Scalpel handle, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: General internal orthopaedic fixation system implantation kit
Susol by Bailey Instruments Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506041883SSPOD6327023 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bailey Instruments Ltd.
- EUDAMED SRN
- GB-MF-000013119
- Authorised Representative
- MD REPS Ltd XI-AR-000040375
Sources (2)
- EUDAMED 5cc3bebc-2950-4055-a019-1378164010c7 61 fields · synced Jul 12, 2026
- FDA UDI e14403a7-f85d-499b-9ee9-215b55f35838 32 fields · synced May 30, 2026