Catalog Number

-

Brand Name

Single Use Injector

Version/Model Number

NM-400U-0425

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

8d8c71b4-f1a6-4eb3-a494-f8479379e501

Public Version Date

May 18, 2022

Public Version Number

3

DI Record Publish Date

September 16, 2020

Package DI Number

14953170422574

Quantity per Package

5

Contains DI Package

04953170422577

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-