Catalog Number

0306-136-000

Brand Name

IVAS

Version/Model Number

0306136000

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

-

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

30e00407-d9a0-4d1d-bb25-3e70aa3e66c6

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

April 04, 2018

Package DI Number

37613327389815

Quantity per Package

6

Contains DI Package

07613327389814

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack