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Badger
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref C8583Ref C8692Ref C8585Ref C8582Ref C8591Ref C8599Ref C8584Ref C8593
Identity
- Trade Name
- BADGER EUDAMEDFDA UDI
- Generic Name
- Cannulated surgical drill bit, reusable FDA UDI
- Device Name
- Orthopedic, Non-active, Drill Bit, Sterile, Reusable, Badger/XO EUDAMEDBADGER CANNULATED BADGER DRILL BIT, 6.5 MM X 229 MM (9") FDA UDIBADGER CANNULATED DRILL BIT, 9.0 MM X 229 MM (9") FDA UDIBADGER CANNULATED BADGER DRILL BIT, 8.5 MM X 229 MM (9") FDA UDIBADGER CANNULATED BADGER DRILL BIT, 7 MM X 229 MM (9") FDA UDIBADGER CANNULATED BADGER DRILL BIT, 5.5 MM X 229 MM (9") FDA UDIBADGER CANNULATED BADGER DRILL BIT, 10.5 MM X 229 MM (9") FDA UDIBADGER CANNULATED BADGER DRILL BIT, 9.5 MM X 229 MM (9") FDA UDIBADGER CANNULATED BADGER DRILL BIT, 8.0 MM X 229 MM (9") FDA UDI
- Model / Reference
- C8583 EUDAMEDFDA UDIC8692 EUDAMEDFDA UDIC8585 EUDAMEDFDA UDIC8582 EUDAMEDFDA UDIC8591 EUDAMEDFDA UDIC8599 EUDAMEDFDA UDIC8584 EUDAMEDFDA UDIC8593 EUDAMEDFDA UDI
- Description
- BADGER CANNULATED BADGER DRILL BIT, 6.5 MM X 229 MM (9") FDA UDIBADGER CANNULATED DRILL BIT, 9.0 MM X 229 MM (9") FDA UDIBADGER CANNULATED BADGER DRILL BIT, 8.5 MM X 229 MM (9") FDA UDIBADGER CANNULATED BADGER DRILL BIT, 7 MM X 229 MM (9") FDA UDIBADGER CANNULATED BADGER DRILL BIT, 5.5 MM X 229 MM (9") FDA UDIBADGER CANNULATED BADGER DRILL BIT, 10.5 MM X 229 MM (9") FDA UDIBADGER CANNULATED BADGER DRILL BIT, 9.5 MM X 229 MM (9") FDA UDIBADGER CANNULATED BADGER DRILL BIT, 8.0 MM X 229 MM (9") FDA UDI
Identifiers
- Catalog Number
- C8593 FDA UDIC8692 FDA UDIC8583 FDA UDIC8582 FDA UDIC8591 FDA UDIC8585 FDA UDIC8584 FDA UDIC8599 FDA UDI
- Primary DI / UDI-DI
- 10845854020142 EUDAMEDFDA UDI10845854020227 EUDAMEDFDA UDI10845854020166 EUDAMEDFDA UDI10845854020135 EUDAMEDFDA UDI10845854020180 EUDAMEDFDA UDI10845854012499 EUDAMEDFDA UDI10845854020159 EUDAMEDFDA UDI10845854020203 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854020142 EUDAMEDB-10845854020227 EUDAMEDB-10845854020166 EUDAMEDB-10845854020135 EUDAMEDB-10845854020180 EUDAMEDB-10845854012499 EUDAMEDB-10845854020159 EUDAMEDB-10845854020203 EUDAMED
- FDA Product Code
- GFG FDA UDI
- EMDN Code
- L0916 ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE EUDAMED
- GMDN Term
- Cannulated surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Belgium 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
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
No
FDA UDI
Category: Fluted surgical drill bit, reusable
Badger by Conmed Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10845854020142 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (24)
- EUDAMED bf2e2973-9688-469b-a212-983bdcc3f59d 61 fields · synced Jul 24, 2026
- EUDAMED cad3c8d5-8aa5-4ea9-8757-3871e794fab4 61 fields · synced May 17, 2026
- EUDAMED 0d17a844-610a-4f1f-ac0b-a04ab3ad1d8b 61 fields · synced May 17, 2026
- EUDAMED 64810de1-9823-4f71-b7f5-2aa6fa801556 61 fields · synced May 18, 2026
- EUDAMED 4a9559ae-d376-4a53-a38e-241fe318d5c0 61 fields · synced May 18, 2026
- EUDAMED 68540737-67d0-4af1-a581-b3f138b312ad 61 fields · synced May 19, 2026
- EUDAMED ff64fa59-9297-4e2e-b9f1-f39c8f4f14d5 61 fields · synced May 19, 2026
- EUDAMED 501cf674-6eb6-490c-9a98-2f265d1fd0ad 61 fields · synced May 19, 2026
- FDA UDI a0161599-fd6e-4e29-9d60-147e80f2a91a 35 fields · synced May 29, 2026
- FDA UDI 63679163-51f2-4b44-9750-47defdbb9c93 35 fields · synced May 29, 2026
- FDA UDI 1db2eb42-bf05-4018-84f8-f3e786edc6f6 35 fields · synced May 30, 2026
- FDA UDI e378eb1d-5d9b-4899-ab07-0d28227a5571 35 fields · synced May 30, 2026
- FDA UDI b27a8e3c-37df-4117-8f95-3e444b4bb3c5 35 fields · synced May 30, 2026
- FDA UDI e676d209-c832-4e06-9d44-2f1ff4c92944 35 fields · synced May 30, 2026
- FDA UDI a8af094e-bdc0-46f5-9e5d-f89e8213a069 35 fields · synced May 30, 2026
- FDA UDI 5a97e569-9540-425b-a305-27fe04c4061e 35 fields · synced May 30, 2026
- EUDAMED cd6d14eb-6d12-46f6-b7eb-11e472aff8bb 61 fields · synced Jun 18, 2026
- EUDAMED 19b45d7a-7967-44df-8734-0da93f4b7768 61 fields · synced Jul 10, 2026
- EUDAMED 8338fd60-4b50-4149-a129-ab50810f1bda 61 fields · synced Jul 10, 2026
- EUDAMED 481c1f95-c4fd-4a48-8149-131797153dbb 61 fields · synced Jul 11, 2026
- EUDAMED aab2918a-e98c-42bd-af37-b24a0a527d8d 61 fields · synced Jul 13, 2026
- EUDAMED 2b7aa803-bb77-46c7-bbcf-bebe337bd818 61 fields · synced Jul 21, 2026
- EUDAMED 4ed7cd19-46b5-4287-9d15-42fbb1cfda7a 61 fields · synced Jul 23, 2026
- EUDAMED 6a85fb83-2971-4f7d-afce-209b08ceff0f 61 fields · synced Jul 24, 2026