Identity
- Trade Name
- Cage Inserter EUDAMEDCage Inserter O-Cage EUDAMEDjoimax® FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- Cage Inserter EUDAMEDFDA UDICage Inserter O-Cage EUDAMED
- Model / Reference
- JCH330008 EUDAMEDFDA UDI
- Description
- Cage Inserter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250337107569 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337107569 EUDAMED42503371INCAINSCV EUDAMED
- Direct Marketing DI
- 04250337107569 EUDAMED
- 510(k) Number
- K151143 FDA UDI
- FDA Product Code
- MAX FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Market of Registration
- Austria EUDAMEDGermany 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
EUDAMEDEUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Cage Inserter 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-04250337107569 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337107569 | 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 f256b7a0-4f69-4be8-a480-6f029343a343 61 fields · synced Jul 15, 2026
- FDA UDI 5b32a79f-67c1-4dac-9c79-5ef92b43a19b 35 fields · synced May 30, 2026
- EUDAMED 1994db40-d3ad-4f7e-bc6b-88546f2a548e 61 fields · synced Jul 15, 2026