Identity
- Trade Name
- Driver EUDAMEDDriver for impression cap and healing cap for bar abutment FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- General Instruments EUDAMEDDriver for impression cap and healing cap for bar abutment, for Ø 3.3/3.8/4.3 mm FDA UDI
- Model / Reference
- J5300.0027 EUDAMEDFDA UDI
- Description
- Driver for impression cap and healing cap for bar abutment, for Ø 3.3/3.8/4.3 mm FDA UDI
Identifiers
- Catalog Number
- J5300.0027 FDA UDI
- Primary DI / UDI-DI
- 04099797996289 EUDAMEDE219J530000271 FDA UDI
- Basic UDI-DI
- 40997970008001000000000H6 EUDAMED
- Secondary DI
- E219J530000271 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 (2)
- EUDAMED 000ab92d-1d23-4cae-9fdb-9b348516fd4d 61 fields · synced Jul 17, 2026
- FDA UDI 451c5442-97ff-4c9f-865f-af1d50c31ea7 35 fields · synced May 24, 2026