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Swann-Morton
EUDAMEDFDA UDIClass I (EU MDR)
Ref 5810 - Non Sterile PD HandleModel 58 Codes
Identity
- Trade Name
- Swann-Morton EUDAMEDSwann Morton Ltd. FDA UDI
- Generic Name
- Scalpel handle, reusable FDA UDI
- Device Name
- Swann-Morton Non Sterile PD 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
- 58 Codes EUDAMED5810 - Non Sterile PD Handle EUDAMEDPD 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
- 5810 FDA UDI
- Primary DI / UDI-DI
- 05033955058104 EUDAMEDFDA UDI
- Basic UDI-DI
- 50339550NONSTPDHANDLEGU EUDAMED
- Direct Marketing DI
- 05033955058104 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 | 50339550NONSTPDHANDLEGU | 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 110c85b0-3dcb-4afc-adc9-971d0308619f 61 fields · synced Jul 29, 2026
- FDA UDI f31e264a-75bd-4efd-b941-50e1b404bd9f 34 fields · synced May 30, 2026