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Swann-Morton
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref L392 - Lance No. 15T Stainless Sterile BladesModel 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 EUDAMEDL392 - Lance No. 15T Stainless Sterile Blades EUDAMEDLANCE No. 15T 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
- L392 FDA UDI
- Primary DI / UDI-DI
- 05033955113926 EUDAMEDFDA UDI
- Basic UDI-DI
- 50339550STERILEBLADES8D EUDAMED
- Unit of Use DI
- 05063043113927 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
Category: Manual scalpel blade, single-use
Swann-Morton by Swann-Morton Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual scalpel blade, single-use.
- Paramount — Paramount Surgimed Limited · Class IIa
- Bard-Parker ® Carbon Rib-Back Blades — Aspen Surgical Products, Inc. · Class I
- SHARD — APPLIED DENTAL, INC. · Class I
- Sterile Stainless Blades — Southmedic Incorporated · Class I
- Paramount — Paramount Surgimed Limited · Class IIa
- SHARD — APPLIED DENTAL, INC. · Class I
- SURGISTAR — Surgistar Inc. · Class I
- Olympus — Olympus Winter & Ibe GmbH · Class II
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 52d113b7-8b0a-4562-aade-eb2127a9894f 61 fields · synced Jul 9, 2026
- FDA UDI e84663d3-c63b-457a-8821-86ca287d2ce6 35 fields · synced May 30, 2026