Identity
- Trade Name
- Endo-Chisel with handle, curved EUDAMEDchisel FDA UDI
- Generic Name
- Orthopaedic chisel FDA UDI
- Device Name
- Curette EUDAMEDEndo-Chisel with handle, curved FDA UDI
- Model / Reference
- TEC372620. EUDAMEDFDA UDI
- Description
- Endo-Chisel with handle, curved FDA UDI
Identifiers
- Catalog Number
- TEC372620. FDA UDI
- Primary DI / UDI-DI
- 04250337117780 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371ABLACUR6H EUDAMED
- Direct Marketing DI
- 04250337117780 EUDAMED
- FDA Product Code
- FZS FDA UDI
- EMDN Code
- L1102 NEUROSURGERY SPATULAS AND DISSECTORS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic chisel 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
Category: Orthopaedic chisel
chisel by Joimax, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI 82cdc982-b438-4c08-ae13-2c979fc72412 36 fields · synced Jul 25, 2026
- EUDAMED 0369c553-f813-4dbb-b50d-2737e7457734 61 fields · synced Jul 25, 2026