Catalog Number

26175

Brand Name

Retrax System Mirror

Version/Model Number

26175

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EIF

Product Code Name

Accessories, Retractor, Dental

Public Device Record Key

ef67e4d1-f525-4812-b22e-d1adee7c6e29

Public Version Date

May 25, 2022

Public Version Number

2

DI Record Publish Date

April 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-