Identity
- Trade Name
- NOVA Basic FDA UDI
- Generic Name
- Stereotactic system application software FDA UDI
- Device Name
- The Navigation Software NOVA Basic provides import of image sets, building the image-based model of patient anatomy, planning of surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy. FDA UDI
- Model / Reference
- 2.6.8 FDA UDI
- Description
- The Navigation Software NOVA Basic provides import of image sets, building the image-based model of patient anatomy, planning of surgical procedures, and displaying the location of navigated instruments relative to the model of the anatomy. FDA UDI
Identifiers
- Catalog Number
- U4 014 FDA UDI
- Primary DI / UDI-DI
- B057U40140 FDA UDI
- FDA Product Code
- PGW FDA UDI
- GMDN Term
- Stereotactic system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Stereotactic system application software
NOVA Basic by Scopis GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Scopis GmbH
Sources (1)
- FDA UDI 180e1ede-24d5-4ea7-b639-2c32bbeeca7a 34 fields · synced May 29, 2026