Catalog Number

ST-003

Brand Name

Soft-Temp

Version/Model Number

ST-003

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

03fe58d2-0785-424b-ac78-ae9280614cb4

Public Version Date

August 06, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

20615089100301

Quantity per Package

20

Contains DI Package

10615089100304

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton