Catalog Number

ST-043

Brand Name

Soft-Temp

Version/Model Number

ST-043

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

Yes

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

-

Product Code

ILO

Product Code Name

Pack, Hot Or Cold, Water Circulating

Public Device Record Key

7c62bb7d-9c6f-4d22-bd63-0fc45f3a49eb

Public Version Date

August 07, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

20615089104309

Quantity per Package

10

Contains DI Package

10615089104302

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton