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Driver
EUDAMEDFDA UDIClass I (EU MDR)
Ref J5300.0039Ref J5300.0031Ref J5300.0040
by ALTATEC GmbH
Identity
- Trade Name
- Driver EUDAMEDDriver for screw implants FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- General Instruments EUDAMEDDriver, extra short, for screw implants, manual/wrench, length 13.7 mm, stainless steel FDA UDI
- Model / Reference
- J5300.0039 EUDAMEDJ5300.0031 EUDAMEDFDA UDIJ5300.0040 EUDAMED
- Description
- Driver, extra short, for screw implants, manual/wrench, length 13.7 mm, stainless steel FDA UDI
Identifiers
- Catalog Number
- J5300.0031 FDA UDI
- Primary DI / UDI-DI
- 04099797992700 EUDAMED04099797996296 EUDAMED04099797992717 EUDAMEDE219J530000311 FDA UDI
- Basic UDI-DI
- 40997970008001000000000H6 EUDAMED
- Secondary DI
- E219J530000391 EUDAMEDE219J530000311 EUDAMEDE219J530000401 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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
No
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
Driver by ALTATEC GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40997970008001000000000H6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (4)
- EUDAMED 10091bb2-c3c9-4fad-ad0b-f643ddcfee67 61 fields · synced Jul 20, 2026
- EUDAMED ad40e934-b614-4341-b6e5-0c7b6f71c7b9 61 fields · synced May 18, 2026
- EUDAMED c613ed5a-1ac4-4e68-891d-30631271fbf9 61 fields · synced May 18, 2026
- FDA UDI 8afe64b6-1692-4aa8-899a-0eb1bf8d1841 35 fields · synced May 30, 2026