Barrel Cutter, Barrel Tip, with distal protection
EUDAMEDFDA UDIClass IIa (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- Barrel Cutter, Barrel Tip, with distal protection EUDAMEDbarrel cutter FDA UDI
- Generic Name
- Arthroscopic shaver system blade, single-use FDA UDI
- Device Name
- Barrel Cutter, Barrel Tip, with distal protection EUDAMEDFDA UDI
- Model / Reference
- JSBBC3235 EUDAMEDFDA UDI
- Description
- Barrel Cutter, Barrel Tip, with distal protection FDA UDI
Identifiers
- Catalog Number
- JSBBC3235 FDA UDI
- Primary DI / UDI-DI
- 04250337103127 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337103127 EUDAMED42503371DEFLRESAK EUDAMED
- Direct Marketing DI
- 04250337103127 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 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
Barrel Cutter, Barrel Tip, with distal protection 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-04250337103127 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337103127 | 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 3fccd82d-58a4-4198-a891-50d828f0d8b8 61 fields · synced Jul 16, 2026
- FDA UDI af1ba93d-d6a2-41b2-9a17-8e0361c49d86 36 fields · synced May 27, 2026
- EUDAMED 43dd3c04-e05d-4133-a0c3-980ee618e014 61 fields · synced Jun 18, 2026