Catalog Number

N720

Brand Name

NeoShades with Tabs Micro

Version/Model Number

10812594010221

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

FOK

Product Code Name

Pad, Neonatal Eye

Public Device Record Key

b45c9c33-121a-4cf3-8db9-4126c4f97798

Public Version Date

July 26, 2022

Public Version Number

2

DI Record Publish Date

May 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-