Identity
- Trade Name
- Drill with Stop 3.6 x 11.5mm EUDAMEDBlue Sky Bio, LLC. FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- DRILL EUDAMEDDrill with Stop 3.6 x 11.5mm FDA UDI
- Model / Reference
- DRILNSTP3611 EUDAMEDFDA UDI
- Description
- Drill with Stop 3.6 x 11.5mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810060220641 EUDAMEDFDA UDI
- Basic UDI-DI
- 081006022DRILLRUC1T4 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Our Drill with Stop 3.6 x 11.5mm device is a high-quality, precision-crafted medical instrument designed for drilling and stopping procedures in various fields of medicine. With its advanced features and rigorous testing, this device ensures precise control and accuracy, making it an essential tool for clinicians and healthcare professionals.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081006022DRILLRUC1T4 | 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 882b646f-37b2-4554-bb1b-d59e559df132 61 fields · synced Aug 3, 2026
- FDA UDI 0576c62e-91f7-4cc6-8275-d764746e4a39 33 fields · synced May 30, 2026