Identity
- Trade Name
- Deflector Spinner Blade EUDAMEDdeflector FDA UDI
- Generic Name
- Spinal shaver system blade FDA UDI
- Device Name
- Deflector Spinner Blade EUDAMEDDeflector Spinner Blade, 12 mm FDA UDI
- Model / Reference
- JSBS361512 EUDAMEDFDA UDI
- Description
- Deflector Spinner Blade, 12 mm FDA UDI
Identifiers
- Catalog Number
- JSBS361512 FDA UDI
- Primary DI / UDI-DI
- 04250337120780 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371SPINDEFLWH EUDAMED
- Direct Marketing DI
- 04250337120780 EUDAMED
- FDA Product Code
- HWE FDA UDI
- EMDN Code
- Z12130585 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Spinal shaver system blade 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
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
No
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
deflector by Joimax, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 803b00d1-bda1-4d57-9ef0-7d00256ea4bc 34 fields · synced Jul 27, 2026
- EUDAMED 315f1dfa-a00f-4eec-b29d-e1873df6e3d6 61 fields · synced Jul 27, 2026