Catalog Number

-

Brand Name

Single Use Injector

Version/Model Number

NM-400U-0423

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"

Yes

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

FBK

Product Code Name

endoscopic injection needle, gastroenterology-urology

Public Device Record Key

12e68051-0046-4c9a-899a-cf5a845a59b6

Public Version Date

May 20, 2022

Public Version Number

3

DI Record Publish Date

September 16, 2020

Package DI Number

14953170422567

Quantity per Package

5

Contains DI Package

04953170422560

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-