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Swann-Morton Limited
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2326-Stitch Cutter Bulk Non-Sterile Disposable Scalpel With GuardModel 19 / 35 /40 Codes
Identity
- Trade Name
- Swann-Morton Limited EUDAMEDFDA UDI
- Generic Name
- Scalpel, single-use FDA UDI
- Device Name
- Swann-Morton Non Sterile Stitch Cutters EUDAMEDA 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
- 19 / 35 /40 Codes EUDAMED2326-Stitch Cutter Bulk Non-Sterile Disposable Scalpel With Guard EUDAMEDSTITCH CUTTER BULK NON STERILE DISPOSABLE SCALPELS WITH GUARD FDA UDI
- Description
- A 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
- 2326 FDA UDI
- Primary DI / UDI-DI
- 05033955023263 EUDAMEDFDA UDI
- Basic UDI-DI
- 50339550NSTSCNE EUDAMED
- Unit of Use DI
- 05063043023264 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
No
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
Radiation Sterilization 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 | 50339550NSTSCNE | 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 6431665f-da10-4248-a912-c3dafff145fb 61 fields · synced Jul 22, 2026
- FDA UDI bc845320-2873-4d78-a05b-f07ad6fd3e3c 35 fields · synced May 30, 2026