Catalog Number

9202

Brand Name

Corneal Light Shield

Version/Model Number

9202

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

K990671,K990671

Product Code

HOZ

Product Code Name

Sponge, Ophthalmic

Public Device Record Key

dd3bfaea-518d-40d8-be64-5adaa4ac3efe

Public Version Date

April 10, 2020

Public Version Number

5

DI Record Publish Date

April 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-