Catalog Number

-

Brand Name

Needle section

Version/Model Number

MAJ-70

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 09, 2022

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

f323d06b-f6ca-460b-a5e3-27dd8dff9b1c

Public Version Date

August 10, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

14953170034012

Quantity per Package

6

Contains DI Package

04953170034015

Package Discontinue Date

August 09, 2022

Package Status

Not in Commercial Distribution

Package Type

-