Catalog Number

-

Brand Name

Thernal 1-Touch

Version/Model Number

Thernal 1-Touch

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 08, 2019

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

8b708d35-44c6-4320-beb5-30326c97c2bd

Public Version Date

September 20, 2021

Public Version Number

3

DI Record Publish Date

August 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-