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Guided Implant Mount NobelActive RP 4.3
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 35888
Identity
- Trade Name
- Guided Implant Mount NobelActive RP 4.3 EUDAMEDNobelActive® FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Guided implant placement tools EUDAMEDGuided Implant Mount NobelActive RP 4.3 FDA UDI
- Model / Reference
- 35888 EUDAMEDFDA UDI
- Description
- Guided Implant Mount NobelActive RP 4.3 FDA UDI
Identifiers
- Catalog Number
- 35888 FDA UDI
- Primary DI / UDI-DI
- 07332747210545 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000001577C EUDAMED
- Direct Marketing DI
- 07332747015515 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.300 Millimeter FDA UDI
Guided Implant Mount NobelActive RP 4.3 by Nobel Biocare AB — 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 | 73327470000001577C | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED 3db88568-77cf-4b6a-b73d-f2e1023fdd54 61 fields · synced Jul 28, 2026
- FDA UDI 53ee71f0-75b1-4457-8db7-ecada6980103 37 fields · synced May 30, 2026