Soft-Temp - Pad for Motorized Cold Therapy Unit Thigh - ADROIT MEDICAL SYSTEMS, INC.

Duns Number:795104769

Device Description: Pad for Motorized Cold Therapy Unit Thigh Non-Sterile 8x14in.

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More Product Details

Catalog Number

ST-014

Brand Name

Soft-Temp

Version/Model Number

ST-014

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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 Details

Product Code

ILO

Product Code Name

Pack, Hot Or Cold, Water Circulating

Device Record Status

Public Device Record Key

05050744-4688-4b5a-a72f-863abd5720ee

Public Version Date

August 07, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

20615089101407

Quantity per Package

10

Contains DI Package

10615089101400

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"ADROIT MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 93