Catalog Number

PT-6-S

Brand Name

Paratherapy Paraffin Bath

Version/Model Number

PT-6-S

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

IMC

Product Code Name

Bath, Paraffin

Public Device Record Key

ef2d1414-135c-4247-bfa2-a230de60d46c

Public Version Date

August 07, 2018

Public Version Number

1

DI Record Publish Date

July 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-