Catalog Number

-

Brand Name

McKesson

Version/Model Number

63-4476

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"

Yes

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

75b27899-64f4-4bc9-8f77-18ecc1df0543

Public Version Date

July 17, 2020

Public Version Number

1

DI Record Publish Date

July 09, 2020

Package DI Number

40612479217971

Quantity per Package

10

Contains DI Package

20612479217960

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case