Catalog Number

-

Brand Name

injeTAK Adjustable Tip Needle 35cm

Version/Model Number

DIS199

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090830,K090830,K090830

Product Code

FBK

Product Code Name

endoscopic injection needle, gastroenterology-urology

Public Device Record Key

07b99dbb-abfb-4893-bf24-b8ffa075ccb4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

20627825000011

Quantity per Package

50

Contains DI Package

10627825000014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-