Scorpion 1-Touch - Scorpion Compress Ophthalmic Warmer - DIGITAL HEAT CORPORATION

Duns Number:080250040

Device Description: Scorpion Compress Ophthalmic Warmer

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Scorpion 1-Touch

Version/Model Number

Scorpion 1-Touch

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2019

Issuing Agency

In HIBCC

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

bba15e48-2a63-4e81-8810-14b4d0bd0a52

Public Version Date

September 20, 2021

Public Version Number

5

DI Record Publish Date

August 07, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIGITAL HEAT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5