Catalog Number

4000-35NH

Brand Name

FRESNEL PRISM AND LENS

Version/Model Number

4000-35NH

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

-

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

HPC

Product Code Name

Set, Lens, Trial, Ophthalmic

Public Device Record Key

a1702b9d-9f78-494d-b7bf-826076dff095

Public Version Date

May 27, 2021

Public Version Number

2

DI Record Publish Date

March 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-