Catalog Number

N5533WH

Brand Name

NeoGlo Disposable

Version/Model Number

10812594013062

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HJN

Product Code Name

Transilluminator, Battery-Powered

Public Device Record Key

c0b8c5f2-0411-4ead-8656-7b5de63b2290

Public Version Date

July 26, 2022

Public Version Number

4

DI Record Publish Date

May 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-