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Swann-Morton Limited
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 0563 - Sabre E11 Sterile Disposable ScapelsModel 05 / 66 / L / P CodesRef 3505 - No. 15 Bulk Non Sterile Disposable Scalpels with Retracting GuardModel 23 / 40 / 35 / LC / NU / PC CodesRef P626 - Paragon Sterile Disposable Scalpel With Retracting Guard Stitch CutterModel 39 / 49 / 36 / P6 CodesRef 0565 - Sabre D15 Sterile Disposable Scalpels
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 EUDAMEDSwann-Morton Non-Sterile Disposable Scalpel EUDAMEDSterile EO Retractable Stitch Cutters EUDAMEDA hand held, manual surgical instrument constructed as a one piece handle and scalepl 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 EUDAMED0563 - Sabre E11 Sterile Disposable Scapels EUDAMED23 / 40 / 35 / LC / NU / PC Codes EUDAMED3505 - No. 15 Bulk Non Sterile Disposable Scalpels with Retracting Guard EUDAMED39 / 49 / 36 / P6 Codes EUDAMEDP626 - Paragon Sterile Disposable Scalpel With Retracting Guard Stitch Cutter EUDAMED0565 - Sabre D15 Sterile Disposable Scalpels EUDAMEDPARAGON STITCH CUTTER STERILE DISPOSABLE SCALPEL WITH RETRACTING GUARD FDA UDI
- Description
- A hand held, manual surgical instrument constructed as a one piece handle and scalepl 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
- P626 FDA UDI
- Primary DI / UDI-DI
- 05033955005634 EUDAMED05063043035052 EUDAMED05033955106263 EUDAMEDFDA UDI05033955005658 EUDAMED
- Basic UDI-DI
- 50339550STERILEDISPS89 EUDAMED50339550NONSTDISPSH9 EUDAMED50339550STERILEEORETSCQ3 EUDAMED
- Unit of Use DI
- 05063043005635 EUDAMED05033955035051 EUDAMED05063043106264 EUDAMED05063043005659 EUDAMED
- FDA Product Code
- FZT FDA UDI
- EMDN Code
- V010102 SCALPELS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMEDV010101 SCALPELS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDV0102 STAPLE REMOVER KNIVES, SINGLE-USE EUDAMED
- GMDN Term
- Scalpel, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMED
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.
- MANI ENT Knife — MANI, INC. · Class I
- 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 (5)
- EUDAMED c725ce04-e4cb-4548-83dc-361de9b77a9a 61 fields · synced Aug 2, 2026
- EUDAMED 208df6c1-84f6-4764-8f87-fca0a359fb11 61 fields · synced May 17, 2026
- EUDAMED d347ee85-6aa0-4e0f-b6a7-253c09edfade 61 fields · synced May 18, 2026
- EUDAMED 5bd1401e-9217-43db-94c5-4f7b231796fd 61 fields · synced May 18, 2026
- FDA UDI 410d54da-18ec-4641-be58-4ec249fa3429 35 fields · synced May 27, 2026