Catalog Number

U600-300G

Brand Name

MR4

Version/Model Number

MR4 Activ G

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080102

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Public Device Record Key

cbeac2f0-7ce0-4f84-b375-64154fd76b05

Public Version Date

November 09, 2020

Public Version Number

4

DI Record Publish Date

September 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-