Catalog Number

607000

Brand Name

Symmetry Olsen

Version/Model Number

607000

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

-

Product Code

HOY

Product Code Name

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

Public Device Record Key

e4e9fe38-e8cd-4a59-9805-88617f3eafd6

Public Version Date

October 25, 2021

Public Version Number

4

DI Record Publish Date

September 06, 2016

Package DI Number

30841785107703

Quantity per Package

12

Contains DI Package

00841785107702

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-