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GUIDED KEY, 6.2mm OD, 3.9mm & 4.6mm DRILL
EUDAMEDFDA UDIClass I (EU MDR)
Ref GK623946
Identity
- Trade Name
- GUIDED KEY, 6.2mm OD, 3.9mm & 4.6mm DRILL EUDAMEDBlue Sky Bio, LLC. FDA UDI
- Generic Name
- Surgical torque wrench adaptor FDA UDI
- Device Name
- DRIVER EUDAMEDGUIDED KEY, 6.2mm OD, 3.9mm & 4.6mm DRILL FDA UDI
- Model / Reference
- GK623946 EUDAMEDFDA UDI
- Description
- GUIDED KEY, 6.2mm OD, 3.9mm & 4.6mm DRILL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810060222027 EUDAMEDFDA UDI
- Basic UDI-DI
- 081006022DRIVERRUC1L5 EUDAMED
- FDA Product Code
- EBL FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Surgical torque wrench adaptor FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3740 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
GUIDED KEY, 6.2mm OD, 3.9mm & 4.6mm DRILL by Blue Sky Bio Llc — 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 | 081006022DRIVERRUC1L5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Blue Sky Bio, LLC
- EUDAMED SRN
- US-MF-000014016
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 3086dd03-f827-4722-a588-6a2c3101584e 61 fields · synced Jul 10, 2026
- FDA UDI ccf20a47-7485-4452-8e26-ca9fdeebee18 33 fields · synced May 30, 2026