Catalog Number

-

Brand Name

injeTAK Adjustable Tip Needle 70cm

Version/Model Number

DIS201

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

a3ae2410-82ab-41e9-8bb7-569dbb0ba6a7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

20627825000028

Quantity per Package

50

Contains DI Package

10627825000021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-