Catalog Number

N55100

Brand Name

NeoGlo Sleeve

Version/Model Number

00812594012716

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

6796a5b9-effa-40d4-a1a6-072435f6b70f

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

-