Identity
- Trade Name
- Wedge 3, Round shank FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- Instruments for foot surgery EUDAMED
- Model / Reference
- AR-301-B102 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- AR-301-B102 FDA UDI
- Primary DI / UDI-DI
- 14053613290965 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2265328134P EUDAMED
- FDA Product Code
- GFF FDA UDI
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Orthopaedic bur, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Germany 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
Yes
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
Yes
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
Instruments for foot surgery by Gebr. Brasseler GmbH & Co. KG — Class IIa — 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 | ++E2265328134P | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Gebr. Brasseler GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000006446
Sources (2)
- EUDAMED 78197fb7-9baa-4675-82c8-75e71a3d4fcf 61 fields · synced Jul 26, 2026
- FDA UDI 7b2c7ca8-7bae-452f-b10e-2a0603497415 33 fields · synced May 25, 2026