Catalog Number

-

Brand Name

andorate® Eye Cornea Protectors

Version/Model Number

GAR001

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HMP

Product Code Name

Pad, Eye

Public Device Record Key

70860f9a-aec3-4883-bb8b-2c756ad31de7

Public Version Date

March 02, 2022

Public Version Number

2

DI Record Publish Date

August 17, 2020

Package DI Number

14897106952332

Quantity per Package

100

Contains DI Package

04897106952335

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box