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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 Second Dilator FDA UDI
Model / Reference
100034 FDA UDI
Description
SonoVision Accessory Kit Second Dilator FDA UDI

Identifiers

Primary DI / UDI-DI
00860001239386 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Interventional radiology percutaneous-access kit, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

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Manufacturer

Manufacturer
Tissue Differentiation Intelligence LLC

Sources (1)

  • FDA UDI 7e4d2b5d-7115-42f5-be1c-e4fd0f7ad5b7 34 fields · synced May 31, 2026