Catalog Number

-

Brand Name

ProGear

Version/Model Number

FM89150

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HOY

Product Code Name

Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Public Device Record Key

b9e7d970-7fd5-4e2f-9ae4-16015eb34b93

Public Version Date

January 01, 2021

Public Version Number

1

DI Record Publish Date

December 24, 2020

Package DI Number

20852212003638

Quantity per Package

8

Contains DI Package

00852212003634

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case