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Disc Space Spreader
EUDAMEDFDA UDIClass I (EU MDR)
Ref JMDS303513
by Joimax GmbH
Identity
- Trade Name
- Disc Space Spreader EUDAMEDIntervertebral Spreader FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, reusable FDA UDI
- Device Name
- Disc Space Spreader EUDAMEDFDA UDI
- Model / Reference
- JMDS303513 EUDAMEDFDA UDI
- Description
- Disc Space Spreader FDA UDI
Identifiers
- Catalog Number
- JMDS303513 FDA UDI
- Primary DI / UDI-DI
- 04250337118350 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337118350 EUDAMED42503371INCASPREK EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Internal spinal fixation procedure kit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Disc Space Spreader by Joimax GmbH — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-04250337118350 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337118350 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax GmbH
- EUDAMED SRN
- DE-MF-000009201
Sources (3)
- EUDAMED 2b0d1bf6-317c-42e4-b553-9a261a2b5d4e 61 fields · synced Aug 2, 2026
- EUDAMED 1991a5c0-0fef-4f0e-a239-76dedbb605bc 61 fields · synced May 19, 2026
- FDA UDI de534e36-434a-4838-aae5-b614ff56fd16 36 fields · synced May 30, 2026