Catalog Number

-

Brand Name

Inrad

Version/Model Number

54622

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

1e0b516b-c2e5-43ca-af6f-342ab90591bc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 01, 2016

Package DI Number

10817295020098

Quantity per Package

10

Contains DI Package

00817295020091

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton