Deflector Bone Resector, Ball-Tip, disposable
EUDAMEDFDA UDIClass IIa (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- Deflector Bone Resector, Ball-Tip, disposable EUDAMEDdeflector FDA UDI
- Generic Name
- Arthroscopic shaver system blade, single-use FDA UDI
- Device Name
- Deflector Bone Resector, Ball-Tip, disposable EUDAMEDFDA UDIDeflector Diamond Abrasor, disposable EUDAMED
- Model / Reference
- JSBDR3115 EUDAMEDFDA UDI
- Description
- Deflector Bone Resector, Ball-Tip, disposable FDA UDI
Identifiers
- Catalog Number
- JSBDR3115 FDA UDI
- Primary DI / UDI-DI
- 04250337118725 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337118725 EUDAMED42503371DEFLABR7K EUDAMED
- Direct Marketing DI
- 04250337118725 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 EUDAMEDGermany 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
Deflector Bone Resector, Ball-Tip, disposable 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-04250337118725 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337118725 | 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 (3)
- EUDAMED ce78ec2e-c015-45c6-950f-00bdbf1c93ed 61 fields · synced Jun 18, 2026
- FDA UDI d46e1171-0aa4-4843-b0fc-b5104b019f0d 36 fields · synced May 29, 2026
- EUDAMED 1c8ae25e-e43b-499a-b7d1-6de0a54a4f9d 61 fields · synced Jun 18, 2026