Identity
- Trade Name
- Guided Drill 4.6 x 10mm EUDAMEDBlue Sky Bio, LLC. FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- DRILL EUDAMEDGuided Drill 4.6 x 10mm FDA UDI
- Model / Reference
- DRILG4610 EUDAMEDFDA UDI
- Description
- Guided Drill 4.6 x 10mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815131029437 EUDAMEDFDA UDI
- Basic UDI-DI
- 081513102DRILLRUC1X6 EUDAMED
- FDA Product Code
- EBL FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Guided Drill 4.6 x 10mm by Blue Sky Bio Llc — 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 | 081513102DRILLRUC1X6 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 b932ec3b-0958-4acf-9a6b-c605cb9c50fc 61 fields · synced Jun 19, 2026
- FDA UDI 8cdd3277-40fd-4ef1-9d92-5aa9d9d60334 33 fields · synced May 30, 2026