Catalog Number

7-1028B

Brand Name

OnLite

Version/Model Number

7-1028B

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

MPU

Product Code Name

Source, Chemiluminescent Light

Public Device Record Key

fc927486-3820-4967-a520-0b4a3aa9c7de

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 05, 2017

Package DI Number

20816908010690

Quantity per Package

10

Contains DI Package

10816908010693

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case