Catalog Number

-

Brand Name

Tommie copper

Version/Model Number

5008LD

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

-

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Public Device Record Key

5e9ded14-ced5-451d-81bd-75f44127684d

Public Version Date

February 03, 2022

Public Version Number

1

DI Record Publish Date

January 26, 2022

Package DI Number

00843041137119

Quantity per Package

48

Contains DI Package

00843041136433

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case