Catalog Number

-

Brand Name

Richmar TheraTouch

Version/Model Number

DQLLLT

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

K131259,K131259

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Public Device Record Key

58cae6a1-645a-4ee7-b23c-9e3dd6b91abd

Public Version Date

November 11, 2019

Public Version Number

3

DI Record Publish Date

February 08, 2019

Package DI Number

80092237621055

Quantity per Package

2

Contains DI Package

00092237621059

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton