DVT - DVT HOME KIT SAMPLE - OSSUR AMERICAS, INC.

Duns Number:139280028

Device Description: DVT HOME KIT SAMPLE

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More Product Details

Catalog Number

DVT-SAMPLE

Brand Name

DVT

Version/Model Number

DVT-SAMPLE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 30, 2019

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)

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

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Device Record Status

Public Device Record Key

2d31cd6d-34ae-47c0-92a0-4216ca6dddb7

Public Version Date

July 22, 2020

Public Version Number

3

DI Record Publish Date

May 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSSUR AMERICAS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 251