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Alef guided ratchet driver long
EUDAMEDFDA UDIClass I (EU MDR)
Ref GDRIMLModel Instruments
Identity
- Trade Name
- Alef guided ratchet driver long EUDAMEDGuided ratchet driver long FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Model / Reference
- Instruments EUDAMEDGDRIML EUDAMEDAL FDA UDI
Identifiers
- Catalog Number
- GDRIML FDA UDI
- Primary DI / UDI-DI
- 07290019897156 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290018434INS83 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Alef guided ratchet driver long by MSDI Medical Systems and Devices International Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 7290018434INS83 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MSDI Medical Systems and Devices International Ltd.
- EUDAMED SRN
- IL-MF-000033949
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (2)
- EUDAMED 5895a7af-15f9-42db-b9af-b7a7ac3b5d24 61 fields · synced Jun 19, 2026
- FDA UDI 0c5e3b8b-ff79-45c5-828d-3084b6b01b1c 33 fields · synced May 30, 2026