Identity
- Trade Name
- Guided Drill Guide RP to Ø3.4mm EUDAMEDNA FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Guided instruments for osteotomy EUDAMEDGuided Drill Guide RP to Ø3.4mm FDA UDI
- Model / Reference
- 32823 EUDAMEDFDA UDI
- Description
- Guided Drill Guide RP to Ø3.4mm FDA UDI
Identifiers
- Catalog Number
- 32823 FDA UDI
- Primary DI / UDI-DI
- 07332747209822 EUDAMEDFDA UDI
- Basic UDI-DI
- 733274700000015578 EUDAMED
- Direct Marketing DI
- 07332747005684 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Sweden 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 3.400 Millimeter FDA UDI
Guided Drill Guide RP to Ø3.4mm 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 | 733274700000015578 | 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 93493e89-5174-487b-bcc7-c31ed6e17bdd 61 fields · synced Jun 19, 2026
- FDA UDI 83c0f5ff-b53c-479d-bb2e-ddf862ae70e9 37 fields · synced May 30, 2026