ice o therm pro - used to apply controlled temperature to a - Saringer Life Science Technologies Inc

Duns Number:243385601

Device Description: used to apply controlled temperature to a specific part of the body.

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More Product Details

Catalog Number

-

Brand Name

ice o therm pro

Version/Model Number

cold

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 08, 2018

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

IRT

Product Code Name

Pad, Heating, Powered

Device Record Status

Public Device Record Key

69703315-705b-4165-a14c-c70b4616ef7b

Public Version Date

July 07, 2020

Public Version Number

4

DI Record Publish Date

December 29, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SARINGER LIFE SCIENCE TECHNOLOGIES INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2