Catalog Number

-

Brand Name

Endo Retract

Version/Model Number

174311

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

K914190,K914190

Product Code

GAD

Product Code Name

RETRACTOR

Public Device Record Key

6ae54815-5c4f-484c-87f8-9d1f3ea1bf30

Public Version Date

October 11, 2022

Public Version Number

3

DI Record Publish Date

August 10, 2018

Package DI Number

20884523000822

Quantity per Package

6

Contains DI Package

10884523000825

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE