Catalog Number

1275

Brand Name

Grafco

Version/Model Number

1275

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

29ff696d-902b-4b21-be22-81f1052084ba

Public Version Date

October 09, 2020

Public Version Number

1

DI Record Publish Date

October 01, 2020

Package DI Number

M36812752

Quantity per Package

200

Contains DI Package

M36812751

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-