Catalog Number

5162

Brand Name

Umbrella Cheek Retractor

Version/Model Number

5162

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

-

Product Code

EIG

Product Code Name

RETRACTOR, ALL TYPES

Public Device Record Key

933ba878-3471-49ac-93a3-d2f2d62473b6

Public Version Date

April 06, 2022

Public Version Number

1

DI Record Publish Date

March 29, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-