Catalog Number

6300-1

Brand Name

FRESNEL PRISM AND LENS

Version/Model Number

6300-1

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

NXR

Product Code Name

Fixation, Vision Training, Binocular

Public Device Record Key

6c697cf9-5bc8-4e42-ad6b-27a932e8d635

Public Version Date

October 19, 2021

Public Version Number

3

DI Record Publish Date

March 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-