Catalog Number

2807/10

Brand Name

Critical Cover

Version/Model Number

2807/10

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

K875302,K875302

Product Code

HOY

Product Code Name

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

Public Device Record Key

6eca59ef-16b6-41f6-8a54-6fe1607a9ad5

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 18, 2020

Package DI Number

20817583023296

Quantity per Package

10

Contains DI Package

00817583023292

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case