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Fixture Grip Wrench Driver
EUDAMEDFDA UDIClass I (EU MDR)
Ref FBGW2.3-SRef FBGW2.3-MRef FBGW3-MRef FBGW3-LRef FBGW2.3-LRef FBGWA-LRef FBGWE-MRef FBGW3-S
Identity
- Trade Name
- Fixture Grip Wrench Driver EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Fixture Grip Wrench Driver EUDAMEDHex Wrench Driver EUDAMED
- Model / Reference
- FBGW2.3-S EUDAMEDFBGW2.3-M EUDAMEDFBGW3-M EUDAMEDFBGW3-L EUDAMEDFBGW2.3-L EUDAMEDFBGWA-L EUDAMEDFDA UDIFBGWE-M EUDAMEDFBGW3-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800020851376 EUDAMED08800020851383 EUDAMED08800020851413 EUDAMED08800020851420 EUDAMED08800020851390 EUDAMED08800020819116 EUDAMEDFDA UDI08800020851352 EUDAMED08800020851406 EUDAMED
- Basic UDI-DI
- B-08800020851376 EUDAMEDB-08800020851383 EUDAMEDB-08800020851413 EUDAMEDB-08800020851420 EUDAMEDB-08800020851390 EUDAMED88000208SRIWP EUDAMEDB-08800020851352 EUDAMEDB-08800020851406 EUDAMED
- Direct Marketing DI
- 08800020819116 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Italy 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
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Fixture Grip Wrench Driver by SNUCONE Co., LTD. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08800020851376 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08800020851376 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Snucone Co., Ltd.
- EUDAMED SRN
- KR-MF-000036358
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (9)
- EUDAMED 44d23967-da44-4565-ad95-4f134a7d736c 61 fields · synced Oct 1, 2026
- EUDAMED edc199ca-f02c-4fac-8011-4efd1ea47023 61 fields · synced May 17, 2026
- EUDAMED 87c8e4fb-608d-42c3-8e98-793fe1702c37 61 fields · synced May 17, 2026
- EUDAMED 53da0fbf-959a-407d-9f43-0d57b96df4dc 61 fields · synced May 17, 2026
- EUDAMED 3d09731b-42af-4363-b354-9d0acae43484 61 fields · synced May 18, 2026
- EUDAMED 890144f3-5821-4198-ad6f-a11d750a78a4 61 fields · synced May 18, 2026
- EUDAMED 300059a6-4cea-4e6b-9e15-2857d4b47666 61 fields · synced May 18, 2026
- EUDAMED a25ec1d7-2012-4df7-b9e7-d065895540eb 61 fields · synced May 18, 2026
- FDA UDI dbbbb59c-b579-4abd-a310-4a65a9fc988a 33 fields · synced May 30, 2026