Catalog Number

-

Brand Name

Endoscopic Injection Needle

Version/Model Number

07-9005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 12, 2018

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

K834403

Product Code

FBK

Product Code Name

Endoscopic Injection Needle, Gastroenterology-Urology

Public Device Record Key

12f04675-6721-47e1-97cc-ba24bfe4ff09

Public Version Date

July 02, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-