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GS-Drill S-5.5, 3.2/2.5mmDx10.0mmL
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GSB1032Model Guided DrillsRef GS1032Model Guided Drills_2
Identity
- Trade Name
- GS-Drill S-5.5, 3.2/2.5mmDx10.0mmL EUDAMEDDrill S-5.5, 3.2/2.5mmDx10.0mmL EUDAMEDFDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Model / Reference
- Guided Drills EUDAMEDGSB1032 EUDAMEDGS1032 EUDAMEDFDA UDIGuided Drills_2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290116774190 EUDAMED07290109300030 EUDAMEDFDA UDI
- Basic UDI-DI
- 729011677GuidDrillCD EUDAMED729010930GuidDrill4C EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3240 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
GS-Drill S-5.5, 3.2/2.5mmDx10.0mmL by Adin Dental Implant Systems Ltd. — Class IIa — 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 | 729011677GuidDrillCD | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Adin Dental Implant Systems LTD.
- EUDAMED SRN
- IL-MF-000014625
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 520708c0-b04d-4cb1-9a1c-56475e0e8fac 61 fields · synced Oct 6, 2026
- FDA UDI 6fbf3839-2715-4db5-8c05-265d38873216 32 fields · synced May 30, 2026
- EUDAMED f3f945b4-7f46-4588-b202-a6e31e982896 61 fields · synced Jul 28, 2026