Identity
- Trade Name
- Shaft Breaker EUDAMEDschaft breaker FDA UDI
- Generic Name
- Internal spinal fixation procedure kit, reusable FDA UDI
- Device Name
- Shaft Breaker EUDAMEDFDA UDI
- Model / Reference
- JMPP1025ST EUDAMEDFDA UDI
- Description
- Shaft Breaker FDA UDI
Identifiers
- Catalog Number
- JMPP1025ST FDA UDI
- Primary DI / UDI-DI
- 04250337107538 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250337107538 EUDAMED42503371INSRBRELH EUDAMED
- Direct Marketing DI
- 04250337107538 EUDAMED
- FDA Product Code
- FZX 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 UDIClass IIa EUDAMED
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Spain 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
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
Shaft Breaker 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-04250337107538 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337107538 | 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 e7afd8e1-ca81-4030-bc01-f27191e5db6f 61 fields · synced Jul 12, 2026
- FDA UDI 67c23fd4-f34f-4333-b111-32f3f22cebb9 36 fields · synced May 30, 2026
- EUDAMED a95eee17-b707-4752-a896-b39dafc669d5 61 fields · synced Jul 12, 2026