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NobelParallel™ CC Guided PureSet Tray
EUDAMEDFDA UDIClass I (EU MDR)
Ref PUR0700
Identity
- Trade Name
- NobelParallel™ CC Guided PureSet Tray EUDAMEDPureSet™ FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Sterilization trays and plates EUDAMEDNobelParallel™ CC Guided PureSet Tray FDA UDI
- Model / Reference
- PUR0700 EUDAMEDFDA UDI
- Description
- NobelParallel™ CC Guided PureSet Tray FDA UDI
Identifiers
- Catalog Number
- PUR0700 FDA UDI
- Primary DI / UDI-DI
- 07332747169041 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000001436Z EUDAMED
- Direct Marketing DI
- 07332747169041 EUDAMED
- 510(k) Number
- K181075 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 — 176.000 Millimeter FDA UDILength — 276.100 Millimeter FDA UDIHeight — 58.900 Millimeter FDA UDI
NobelParallel™ CC Guided 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 eeecca07-845d-42a2-bba9-e81817dcfc6c 61 fields · synced Jul 25, 2026
- FDA UDI e41e58eb-bdda-4f2f-9275-3ef02912be68 38 fields · synced May 27, 2026