Diamond Abrasor, Ball Tip, Coarse
EUDAMEDFDA UDIClass IIa (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- Diamond Abrasor, Ball Tip, Coarse EUDAMEDDiamond Abrasor, Ball Tip EUDAMEDDiamon Abrasor FDA UDI
- Generic Name
- Arthroscopic shaver system blade, single-use FDA UDI
- Device Name
- Diamond Abrasor, Ball Tip, Coarse EUDAMEDFDA UDIDiamond Abrasor, Ball Tip EUDAMEDFDA UDIBarrel Cutter, Barrel Tip, with distal protection EUDAMED
- Model / Reference
- JSBDA243534C EUDAMEDFDA UDIJSBDA244544C EUDAMEDFDA UDIJSBDA194543C EUDAMEDFDA UDIJSBDA274544C EUDAMEDFDA UDIJSBDA243534 EUDAMEDFDA UDIJSBDA324544C EUDAMEDJSBDA154544C EUDAMED
- Description
- Diamond Abrasor, Ball Tip, Coarse FDA UDIDiamond Abrasor, Ball Tip FDA UDI
Identifiers
- Catalog Number
- JSBDA244544C FDA UDIJSBDA243534C FDA UDIJSBDA274544C FDA UDIJSBDA243534 FDA UDIJSBDA194543C FDA UDI
- Primary DI / UDI-DI
- 04250337115007 EUDAMEDFDA UDI04250337114987 EUDAMEDFDA UDI04250337115069 EUDAMEDFDA UDI04250337116479 EUDAMEDFDA UDI04250337108115 EUDAMEDFDA UDI04250337120704 EUDAMED04250337120148 EUDAMED
- Basic UDI-DI
- B-04250337115007 EUDAMEDB-04250337114987 EUDAMEDB-04250337115069 EUDAMEDB-04250337116479 EUDAMEDB-04250337108115 EUDAMED42503371DEFLRESAK EUDAMED
- Direct Marketing DI
- 04250337115069 EUDAMED04250337115007 EUDAMED04250337120704 EUDAMED04250337116479 EUDAMED04250337120148 EUDAMED04250337108115 EUDAMED04250337114987 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- Z12130585 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Arthroscopic shaver system blade, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Germany EUDAMEDAustria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Spinal shaver system blade
Diamond Abrasor, Ball Tip, Coarse by Joimax GmbH — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal shaver system blade.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337115007 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337115007 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (18)
- EUDAMED d7003029-8a9a-4df7-beb7-67d1e8f59ca4 61 fields · synced Aug 3, 2026
- EUDAMED da3c2bd4-d542-433e-a403-21930e98d4b4 61 fields · synced May 17, 2026
- EUDAMED 0e8d60e1-e471-4051-9cef-b84d21f755dd 61 fields · synced May 18, 2026
- EUDAMED b75a07c1-8800-4429-b987-97395a5f8f5a 61 fields · synced May 18, 2026
- EUDAMED 5fc9ce6c-b399-4f8c-b515-3c1ca8a7a450 61 fields · synced May 19, 2026
- FDA UDI 5886afbd-e2c5-4eb2-8698-2cd754d82f49 36 fields · synced May 29, 2026
- FDA UDI 799c0440-8407-4495-b128-d270f442c268 36 fields · synced May 30, 2026
- FDA UDI e1db6139-b098-40e1-81ec-075672951f6c 36 fields · synced May 30, 2026
- FDA UDI 2aa5e38b-d87b-4790-a7a1-a9f757599fe9 36 fields · synced May 30, 2026
- FDA UDI 9d3d1eab-201b-4036-8023-f37ec428300c 36 fields · synced May 30, 2026
- EUDAMED 2f40949c-762b-4380-8ae5-b2f9b2d42966 61 fields · synced Jul 8, 2026
- EUDAMED 7394e141-c584-4308-a94a-9d993d4f5df1 61 fields · synced Jul 9, 2026
- EUDAMED fc7bbf57-1b13-4d17-b588-9c9202f2e701 61 fields · synced Jul 9, 2026
- EUDAMED 06c293c8-6e2d-42ab-8fbf-1c9a142dd4a2 61 fields · synced Jul 9, 2026
- EUDAMED 09598747-3f6e-4bb0-9f76-b000ac44e732 61 fields · synced Jul 11, 2026
- EUDAMED b97549de-c932-4ca1-9997-0ed7ddd51ed9 61 fields · synced Jul 13, 2026
- EUDAMED 6afac0ca-fc4f-47f2-a198-e981f1cff1ea 61 fields · synced Jul 22, 2026
- EUDAMED 9d84c268-e775-42e3-a404-582a70f9f8ff 61 fields · synced Aug 3, 2026