Catalog Number

-

Brand Name

Inrad

Version/Model Number

680514

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

K093399,K093399

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

a5e0a9b8-6a45-4034-bda5-19c6b0ab9580

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

December 01, 2016

Package DI Number

10817295020784

Quantity per Package

5

Contains DI Package

00817295020787

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton