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Bone Resector, Ball Tip
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref JSBBR244543Ref JSBBR273533
by Joimax GmbH
Identity
- Trade Name
- Bone Resector, Ball Tip EUDAMEDbone resector FDA UDI
- Generic Name
- Arthroscopic shaver system blade, single-use FDA UDI
- Device Name
- Bone Resector, Ball Tip EUDAMEDFDA UDIBarrel Cutter, Barrel Tip, with distal protection EUDAMED
- Model / Reference
- JSBBR244543 EUDAMEDFDA UDIJSBBR273533 EUDAMEDFDA UDI
- Description
- Bone Resector, Ball Tip FDA UDI
Identifiers
- Catalog Number
- JSBBR244543 FDA UDIJSBBR273533 FDA UDI
- Primary DI / UDI-DI
- 04250337115458 EUDAMEDFDA UDI04250337116332 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337115458 EUDAMEDB-04250337116332 EUDAMED42503371DEFLRESAK EUDAMED
- Direct Marketing DI
- 04250337116332 EUDAMED04250337115458 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
- Austria EUDAMEDSpain EUDAMEDGermany 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
Yes
FDA UDI
Category: Spinal shaver system blade
Bone Resector, Ball Tip 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
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04250337115458 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337115458 | 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 (6)
- EUDAMED c344b5c5-420f-4ff9-8551-7388236df9f1 61 fields · synced Jul 21, 2026
- EUDAMED e287d2ae-094e-4616-be59-5225f36a4607 61 fields · synced May 18, 2026
- FDA UDI eb5b0a72-3fe7-4166-b840-465aa15dcfb0 36 fields · synced May 30, 2026
- FDA UDI f580fdbe-eee7-46f9-9e67-f5c6834290e6 36 fields · synced May 30, 2026
- EUDAMED c3b870f7-b8f8-4f86-bc7f-9d1c2eba2aef 61 fields · synced Jul 10, 2026
- EUDAMED 183094a9-af17-4cbb-ba3f-2f4a20b03c2f 61 fields · synced Jul 16, 2026