Catalog Number

TVC-MC8-B1

Brand Name

TVC Controller Sterile Barrier

Version/Model Number

TVC-MC8-B1

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

Yes

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

K141682,K141682

Product Code

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Public Device Record Key

0dfb2aec-2c42-434a-9e48-d6ba2b426478

Public Version Date

February 06, 2020

Public Version Number

6

DI Record Publish Date

August 22, 2016

Package DI Number

00857595006012

Quantity per Package

5

Contains DI Package

00857595006005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton