Identity
- Trade Name
- Nobel Biocare N1™ PureSet Tray EUDAMEDPureSet™ FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Sterilization trays and plates EUDAMEDNobel Biocare N1™ PureSet Tray FDA UDI
- Model / Reference
- PUR0400 EUDAMEDFDA UDI
- Description
- Nobel Biocare N1™ PureSet Tray FDA UDI
Identifiers
- Catalog Number
- PUR0400 FDA UDI
- Primary DI / UDI-DI
- 07332747167184 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000001436Z EUDAMED
- Direct Marketing DI
- 07332747167184 EUDAMED
- 510(k) Number
- K191475 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- S0199 DEVICES FOR STERILISATION AND PACKAGING (EXCLUDING CAT. D - Z) - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
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
- Width — 115.000 Millimeter FDA UDILength — 122.100 Millimeter FDA UDIHeight — 45.600 Millimeter FDA UDI
Nobel Biocare N1™ PureSet Tray 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 | 73327470000001436Z | 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 c209b9a5-ab9a-4f6d-982c-62d89b283cff 61 fields · synced Sep 17, 2026
- FDA UDI bdc4b48e-573f-4a43-921f-7c3ca4a466f9 38 fields · synced May 30, 2026