Catalog Number

-

Brand Name

Convex probe

Version/Model Number

VE6-V

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170374,K170374

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

e0c43196-334d-4fbd-9df2-c6026ef1deba

Public Version Date

September 05, 2022

Public Version Number

5

DI Record Publish Date

June 16, 2017

Package DI Number

06945121411714

Quantity per Package

1

Contains DI Package

06945121411448

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-