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Swann-Morton
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 0312 - Stainless Surgical Blade No. 25Model 02 / 03 / L / P Codes
Identity
- Trade Name
- Swann-Morton EUDAMEDSwann Morton Ltd. FDA UDI
- Generic Name
- Manual scalpel blade, single-use FDA UDI
- Device Name
- Swann-Morton Sterile Standard Surgical Blade EUDAMEDBlade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be attached to the scalpel handle. It is capable of cutting through tissue when moved with downward pressure. This device is disposable. FDA UDI
- Model / Reference
- 02 / 03 / L / P Codes EUDAMED0312 - Stainless Surgical Blade No. 25 EUDAMEDNo. 25 STAINLESS STERILE BLADES FDA UDI
- Description
- Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be attached to the scalpel handle. It is capable of cutting through tissue when moved with downward pressure. This device is disposable. FDA UDI
Identifiers
- Catalog Number
- 0312 FDA UDI
- Primary DI / UDI-DI
- 05033955003128 EUDAMEDFDA UDI
- Basic UDI-DI
- 50339550STERILEBLADES8D EUDAMED
- Unit of Use DI
- 05063043003129 EUDAMED
- FDA Product Code
- GES FDA UDI
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Manual scalpel blade, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
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
Swann-Morton by Swann-Morton Ltd — Class IIa — 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 | 50339550STERILEBLADES8D | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 2888d1a4-8f62-4f4e-9cb3-dcc2c1914505 61 fields · synced Jul 17, 2026
- FDA UDI 0344a03b-2f8e-4d29-9b74-93ca71b4438d 35 fields · synced May 30, 2026