Identity
- Trade Name
- PureSet™ FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- NobelActive®/NobelParallel™ CC PureSet Plate FDA UDI
- Model / Reference
- PUR0201 FDA UDI
- Description
- NobelActive®/NobelParallel™ CC PureSet Plate FDA UDI
Identifiers
- Catalog Number
- PUR0201 FDA UDI
- Primary DI / UDI-DI
- 07332747150001 FDA UDI
- 510(k) Number
- K181075 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
- Length — 260.000 Millimeter FDA UDIHeight — 1.500 Millimeter FDA UDIWidth — 165.000 Millimeter FDA UDI
Category: Instrument tray, reusable
PureSet™ by Nobel Biocare AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Instrument tray, reusable.
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- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- ASELTECH — Asel Tibbi Aletler A.S. · Class I
Cleared under the same submission
K181075 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AG
Sources (1)
- FDA UDI b9029fe4-5ee4-4ab4-b174-5436131c8344 37 fields · synced Jun 8, 2026