Catalog Number

EVIVA_1213-20

Brand Name

EVIVA_1213-20

Version/Model Number

EVIVA_1213-20

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180233,K180233,K180233

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

3edb318a-6351-446d-a423-124cc404168c

Public Version Date

July 12, 2019

Public Version Number

6

DI Record Publish Date

July 26, 2016

Package DI Number

35420045504992

Quantity per Package

5

Contains DI Package

15420045504998

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX