joimax® Needle and Guide Wire Set
EUDAMEDFDA UDIClass IIa (EU MDR)
by Joimax GmbH
Identity
- Trade Name
- joimax® Needle and Guide Wire Set EUDAMEDNeedle / Guide Wire - Set FDA UDI
- Generic Name
- Lumbar decompression procedure kit FDA UDI
- Device Name
- joimax® Needle and Guide Wire Set EUDAMEDFDA UDI
- Model / Reference
- JMSN18GW EUDAMEDFDA UDIJMSN18GW11 EUDAMEDFDA UDI
- Description
- joimax® Needle and Guide Wire Set FDA UDI
Identifiers
- Catalog Number
- JMSN18GW11 FDA UDIJMSN18GW FDA UDI
- Primary DI / UDI-DI
- 04250337103271 EUDAMEDFDA UDI04250337103929 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337103271 EUDAMEDB-04250337103929 EUDAMED42503371ACNENGW97 EUDAMED
- Direct Marketing DI
- 04250337103929 EUDAMED04250337103271 EUDAMED
- FDA Product Code
- GAA FDA UDI
- EMDN Code
- V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER EUDAMEDA019099 NEEDLES FOR OTHER PROCEDURES - OTHER EUDAMED
- GMDN Term
- Lumbar decompression procedure kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 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: General internal orthopaedic fixation system implantation kit
joimax® Needle and Guide Wire Set by Joimax GmbH — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-04250337103271 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04250337103271 | 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 561c69e6-e965-4e07-b731-854c369ea8fe 61 fields · synced Jul 24, 2026
- EUDAMED 217202f7-7906-4893-817e-9c7d6cea1846 61 fields · synced May 18, 2026
- FDA UDI f811eb5b-b0f0-45f4-b199-b89a87ba2fa6 36 fields · synced May 30, 2026
- FDA UDI 0c438f5d-f986-4cb6-9d60-50982caccf28 36 fields · synced May 30, 2026
- EUDAMED cb4b6cf2-243b-4752-8809-c717264e9c9f 61 fields · synced Jul 24, 2026
- EUDAMED 11f04096-dd74-462d-b968-0a8662ee3b73 61 fields · synced Jul 24, 2026