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Swann-Morton Limited
EUDAMEDFDA UDIClass I (EU MDR)
Ref 3626 - Sterile Disposable Scalpel with Retracting Guard Stitch CutterModel 39 / 49 / 36 / P6 Codes
Identity
- Trade Name
- Swann-Morton Limited EUDAMEDSwann Morton Ltd. FDA UDI
- Generic Name
- Scalpel, single-use FDA UDI
- Device Name
- Sterile 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
- 39 / 49 / 36 / P6 Codes EUDAMED3626 - Sterile Disposable Scalpel with Retracting Guard Stitch Cutter EUDAMEDSTITCH 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
- 3626 FDA UDI
- Primary DI / UDI-DI
- 05033955036263 EUDAMEDFDA UDI
- Basic UDI-DI
- 50339550STERILEEORETSCQ3 EUDAMED
- Unit of Use DI
- 05063043036264 EUDAMED
- FDA Product Code
- FZT FDA UDI
- EMDN Code
- V0102 STAPLE REMOVER KNIVES, SINGLE-USE EUDAMED
- GMDN Term
- Scalpel, single-use 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
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 Limited 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 | 50339550STERILEEORETSCQ3 | 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 74f46aa8-534e-4336-8464-748ab5c91ad4 61 fields · synced Jul 17, 2026
- FDA UDI 44240a53-1d92-47b9-a548-87d355a52e39 35 fields · synced May 29, 2026