Catalog Number

7013-0001

Brand Name

ThermalX

Version/Model Number

361

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FME

Product Code Name

Gown, Examination

Public Device Record Key

cf23abc7-9395-4872-8218-4f8841f4b069

Public Version Date

October 14, 2019

Public Version Number

1

DI Record Publish Date

October 04, 2019

Package DI Number

20615089701300

Quantity per Package

25

Contains DI Package

10615089701303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton