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Swann-Morton
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 9942 - Silvers Sterile Skin Graft BladesModel 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 EUDAMED9942 - Silvers Sterile Skin Graft Blades EUDAMEDSILVERS STERILE SKIN GRAFT BLADES FDA UDI
- Description
- Dermatome -A surgical instrument used for harvesting skin for grafting purposes. FDA UDI
Identifiers
- Catalog Number
- 9942 FDA UDI
- Primary DI / UDI-DI
- 05033955099428 EUDAMEDFDA UDI
- Basic UDI-DI
- 50339550STERILESKGRAFTRT EUDAMED
- Unit of Use DI
- 05063043099429 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
Similar devices
Also classified as Cranial bur, single-use.
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- Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
- J-Notch Burs — Stryker Instruments · Class IIa
- 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 e2baeb1d-4ad2-41f9-b1b5-1d0a40a6ad81 61 fields · synced May 30, 2026
- FDA UDI d6ecb365-99ab-4201-bbb7-10f808bd1e48 35 fields · synced May 30, 2026