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NiTi Nerve Hook, superelastic
EUDAMEDFDA UDIClass I (EU MDR)
Ref TNH262548Ref TNH272533Ref TNH322533.
by Joimax GmbH
Identity
- Trade Name
- NiTi Nerve Hook, superelastic EUDAMEDnerve hook FDA UDI
- Generic Name
- Nerve/vessel retractor FDA UDI
- Device Name
- NiTi Nerve Hook, superelastic EUDAMEDFDA UDIExamining Hook EUDAMED
- Model / Reference
- TNH262548 EUDAMEDFDA UDITNH322533. EUDAMEDFDA UDITNH272533 EUDAMED
- Description
- NiTi Nerve Hook, superelastic FDA UDI
Identifiers
- Catalog Number
- TNH262548 FDA UDITNH322533. FDA UDI
- Primary DI / UDI-DI
- 04250337108344 EUDAMEDFDA UDI04250337116288 EUDAMEDFDA UDI04250337119623 EUDAMED
- Basic UDI-DI
- B-04250337108344 EUDAMED42503371PALPHOOHD EUDAMED
- Direct Marketing DI
- 04250337119623 EUDAMED04250337116288 EUDAMED
- FDA Product Code
- GEG FDA UDI
- EMDN Code
- L110502 NERVES AND VESSELS HOOK RETRACTORS, REUSABLE EUDAMEDL110599 NEUROSURGERY SPREADERS AND RETRACTORS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Nerve/vessel retractor 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
NiTi Nerve Hook, superelastic 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-04250337108344 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04250337108344 | 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 (6)
- EUDAMED 52d3b8af-47d4-4c03-8639-222bd91a781e 61 fields · synced Jul 24, 2026
- EUDAMED fec37031-e066-4700-ace1-83ad6bd8f4aa 61 fields · synced May 18, 2026
- FDA UDI da37947a-776a-46d9-91c7-07340cb9c581 36 fields · synced May 29, 2026
- FDA UDI 48bd80ef-c8ce-4b96-8e59-731024328c0b 36 fields · synced May 30, 2026
- EUDAMED 1f75462d-1f17-4aae-b034-4167157e01ff 61 fields · synced Jul 9, 2026
- EUDAMED aa596df1-0f9c-456b-a33f-9ecc71214eea 61 fields · synced Jul 24, 2026