Identity
- Trade Name
- NovaGuide™ 2 Intelligent Ultrasound System FDA UDI
- Generic Name
- Noninvasive vascular ultrasound system, line-powered FDA UDI
- Model / Reference
- 05-00030 FDA UDI
Identifiers
- Catalog Number
- NSC-NVGSYS2 FDA UDI
- Primary DI / UDI-DI
- 00850681007399 FDA UDI
- 510(k) Number
- K213279 FDA UDI
- FDA Product Code
- IYN FDA UDIITX FDA UDI
- GMDN Term
- Noninvasive vascular ultrasound system, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1570 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Noninvasive vascular ultrasound system probeNoninvasive vascular ultrasound systemNoninvasive vascular ultrasound system, line-powered
NovaGuide™ 2 Intelligent Ultrasound System by Novasignal Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K213279 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
- Novasignal Corporation
Sources (1)
- FDA UDI fe79af00-96b3-4964-a360-d3543bfd1aa9 34 fields · synced May 29, 2026