← Back to catalogue

SonoVision

FDA UDI

Class I (US FDA UDI)

by Tissue Differentiation Intelligence LLC

Identity

Trade Name
SonoVision FDA UDI
Generic Name
Interventional radiology percutaneous-access kit, reusable FDA UDI
Device Name
SonoVision Accessory Kit Stabilzer Tube FDA UDI
Model / Reference
100021 FDA UDI
Description
SonoVision Accessory Kit Stabilzer Tube FDA UDI

Identifiers

Primary DI / UDI-DI
00860001239324 FDA UDI
FDA Product Code
GAD FDA UDI
GMDN Term
Interventional radiology percutaneous-access kit, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Interventional radiology percutaneous-access kit, reusable

SonoVision by Tissue Differentiation Intelligence LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Interventional radiology percutaneous-access kit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Tissue Differentiation Intelligence LLC

Sources (1)

  • FDA UDI bfa19de3-6821-4b6e-87a3-78388b939590 35 fields · synced Jun 1, 2026