Catalog Number

-

Brand Name

Inrad

Version/Model Number

691520

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

GAA

Product Code Name

Needle, Aspiration And Injection, Disposable

Public Device Record Key

cb1bfb09-923f-4b7a-820c-ee030d4650d1

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

December 01, 2016

Package DI Number

10817295021002

Quantity per Package

10

Contains DI Package

00817295021005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton