Identity
- Trade Name
- Rasp Cages 13 EUDAMEDraspatorium cage FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, reusable FDA UDI
- Device Name
- Rasp Cages 13 EUDAMEDFDA UDIRasp O-Cage EUDAMED
- Model / Reference
- ELO643513R EUDAMEDFDA UDI
- Description
- Rasp Cages 13 FDA UDI
Identifiers
- Catalog Number
- ELO643513R FDA UDI
- Primary DI / UDI-DI
- 04250337107743 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337107743 EUDAMED42503371INCARASD3 EUDAMED
- FDA Product Code
- GAC 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
- 878.4800 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
Rasp Cages 13 by Joimax GmbH — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250337107743 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-04250337107743 | 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 61e87bb2-4575-4d5d-b7c7-593662a0cc75 61 fields · synced Jul 16, 2026
- EUDAMED 8e325177-1d56-4481-b025-a6a4038be116 61 fields · synced May 17, 2026
- FDA UDI 04d0c778-c747-4d7d-b566-d64b1185d49c 36 fields · synced May 26, 2026