Catalog Number

N555AQ

Brand Name

NeoGlo - Aqua (N555AQ-B)

Version/Model Number

00812594012679

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"

Yes

For Single-Use

-

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

597f97ea-4f69-4ba1-ab61-0c71918e30f3

Public Version Date

July 26, 2022

Public Version Number

5

DI Record Publish Date

January 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-