Identity
- Trade Name
- Guided Pilot Drill Sleeve 1.5mm EUDAMEDNobel Biocare® FDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Device Name
- Guided sleeves EUDAMEDGuided Pilot Drill Sleeve 1.5mm FDA UDI
- Model / Reference
- 300438 EUDAMEDFDA UDI
- Description
- Guided Pilot Drill Sleeve 1.5mm FDA UDI
Identifiers
- Catalog Number
- 300438 FDA UDI
- Primary DI / UDI-DI
- 07332747176438 EUDAMEDFDA UDI
- Basic UDI-DI
- 733274700000013572 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Surgical drill guide, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
High-level Disinfectant FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 1.500 Millimeter FDA UDI
Guided Pilot Drill Sleeve 1.5mm by Nobel Biocare AB — 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 | 733274700000013572 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED e7a8e38e-a920-438c-b8fe-a203936abe37 61 fields · synced Jun 18, 2026
- FDA UDI 52acfc3d-46f7-4e5a-86da-6090fd0299cd 38 fields · synced May 30, 2026