Catalog Number

IN12-255232302

Brand Name

NA

Version/Model Number

IN12-255232302

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150434,K150434,K150434

Product Code

FBK

Product Code Name

Endoscopic Injection Needle, Gastroenterology-Urology

Public Device Record Key

6d204377-b94b-4bb1-8542-9d43cf349bc0

Public Version Date

April 12, 2021

Public Version Number

4

DI Record Publish Date

March 10, 2016

Package DI Number

26932503533243

Quantity per Package

10

Contains DI Package

16932503533246

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case