Catalog Number

7700512

Brand Name

FUSION-DOE Light System

Version/Model Number

7700512

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

-

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

K101140

Product Code

NXV

Product Code Name

Diagnostic Light, Soft Tissue Detector

Public Device Record Key

c0f4946a-576c-4e2e-a867-6b1c2935c6e2

Public Version Date

January 25, 2022

Public Version Number

2

DI Record Publish Date

August 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-