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Swann-Morton
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6051 - SF1 Fine Surgical HandleModel 60 Codes
Identity
- Trade Name
- Swann-Morton EUDAMEDSwann Morton Ltd. FDA UDI
- Generic Name
- Scalpel handle, reusable FDA UDI
- Device Name
- Swann-Morton Non Sterile Fine Handle EUDAMEDKnife/blade handle. A metal surgical instrument e.g. stainless steel or brass, designed to mount a compatible blade used for cutting or dissecting tissue. FDA UDI
- Model / Reference
- 60 Codes EUDAMED6051 - SF1 Fine Surgical Handle EUDAMEDSF1 FINE SURGICAL HANDLE FDA UDI
- Description
- Knife/blade handle. A metal surgical instrument e.g. stainless steel or brass, designed to mount a compatible blade used for cutting or dissecting tissue. FDA UDI
Identifiers
- Catalog Number
- 6051 FDA UDI
- Primary DI / UDI-DI
- 05033955060510 EUDAMEDFDA UDI
- Basic UDI-DI
- 50339550NONSTFINEHANDLE4K EUDAMED
- Direct Marketing DI
- 05033955060510 EUDAMED
- FDA Product Code
- GDZ FDA UDI
- EMDN Code
- L010103 HANDLES FOR SCALPELS, REUSABLE EUDAMED
- GMDN Term
- Scalpel handle, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France 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
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
Swann-Morton by Swann-Morton 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 | 50339550NONSTFINEHANDLE4K | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Swann-Morton Ltd
- EUDAMED SRN
- GB-MF-000001890
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED b266274a-ca31-47b2-8a5b-d4c34260c96d 61 fields · synced Jun 6, 2026
- FDA UDI 39918089-3a2c-4424-bc5a-72ed45386537 34 fields · synced May 30, 2026