Catalog Number

-

Brand Name

Thera-Cream

Version/Model Number

TCT004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K032239

Product Code

GYB

Product Code Name

Media, Electroconductive

Public Device Record Key

70d1fc78-d491-4f56-ad30-2a0c1d9541a0

Public Version Date

April 29, 2020

Public Version Number

1

DI Record Publish Date

April 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-