Catalog Number

101087

Brand Name

Endoscopic Injection Needle

Version/Model Number

101087

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"

-

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

K172227,K172227

Product Code

FBK

Product Code Name

Endoscopic Injection Needle, Gastroenterology-Urology

Public Device Record Key

f30b09bd-cca6-4f1a-9c07-3a63356bc263

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 25, 2017

Package DI Number

10858015005940

Quantity per Package

5

Contains DI Package

00858015005943

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton