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Swann-Morton
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2201 - Skin Graft Blade SG3Model 22 / 99 / PS 50 Codes
Identity
- Trade Name
- Swann-Morton EUDAMEDSwann Morton Ltd. FDA UDI
- Generic Name
- Dermatome blade, single-use FDA UDI
- Device Name
- Swann-Morton Sterile Skin Graft Blades EUDAMEDDermatome. A surgical instrument used for harvesting skin for grafting purposes. FDA UDI
- Model / Reference
- 22 / 99 / PS 50 Codes EUDAMED2201 - Skin Graft Blade SG3 EUDAMEDSKIN GRAFT BLADES SG3 FDA UDI
- Description
- Dermatome. A surgical instrument used for harvesting skin for grafting purposes. FDA UDI
Identifiers
- Catalog Number
- 2201 FDA UDI
- Primary DI / UDI-DI
- 05033955022013 EUDAMEDFDA UDI
- Basic UDI-DI
- 50339550STERILESKGRAFTRT EUDAMED
- Unit of Use DI
- 05063043022014 EUDAMED
- FDA Product Code
- FZW FDA UDI
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dermatome 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: Cranial bur, single-use
Swann-Morton by Swann-Morton Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Cranial bur, single-use.
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- Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
- GT PODO 5 mm rund/round Schaft 2, 35 x 35 — LUKAS-ERZETT GmbH & Co.KG · 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 | 50339550STERILESKGRAFTRT | 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 9256607d-2d6b-4e00-9f9a-652839417d4b 61 fields · synced Jul 11, 2026
- FDA UDI ffe4fc81-3652-48b7-8ae7-300095913d7c 35 fields · synced May 30, 2026