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Swann-Morton Limited
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 0504 - No. 12 Sterile Disposable ScalpelModel 05 / 66 / L / P Codes
Identity
- Trade Name
- Swann-Morton Limited EUDAMEDSwann Morton Ltd. FDA UDI
- Generic Name
- Scalpel, single-use FDA UDI
- Device Name
- Swann-Morton Sterile Disposable Scalpels EUDAMEDA sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device. FDA UDI
- Model / Reference
- 05 / 66 / L / P Codes EUDAMED0504 - No. 12 Sterile Disposable Scalpel EUDAMEDNo. 12 STERILE DISPOSABLE SCALPELS FDA UDI
- Description
- A sterile, hand-held, manual surgical instrument constructed as a one piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single use device. FDA UDI
Identifiers
- Catalog Number
- 0504 FDA UDI
- Primary DI / UDI-DI
- 05033955005047 EUDAMEDFDA UDI
- Basic UDI-DI
- 50339550STERILEDISPS89 EUDAMED
- Unit of Use DI
- 05063043005048 EUDAMED
- FDA Product Code
- GDX FDA UDI
- EMDN Code
- V010102 SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
- GMDN Term
- Scalpel, 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: Scalpel, single-use
Swann-Morton Limited by Swann-Morton Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Scalpel, single-use.
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- Unique Edge — Unique Technologies, Inc. · Class I
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
- Bard-Parker ® Disposable Scalpels — Aspen Surgical Products, Inc. · Class I
- Sharpoint — Surgical Specialties México, S. de R.L. de C.V. · Class I
- comknife® — Beijing Bohai Kangyuan Medical Devices Co., Ltd. · Class I
- Stylus — Surgical Specialties México, S. de R.L. de C.V. · Class I
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 | 50339550STERILEDISPS89 | 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 2ab82031-ec56-4b0c-80b5-0f81b9c14820 61 fields · synced Jul 9, 2026
- FDA UDI 73f00585-4940-4169-b509-d9be0e2b330c 35 fields · synced May 30, 2026