Catalog Number

-

Brand Name

DVT-PRO

Version/Model Number

DS500

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

-

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

K203353,K203353,K203353

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

058c82c3-25ab-4531-9b62-04ce7e128ba7

Public Version Date

June 30, 2021

Public Version Number

1

DI Record Publish Date

June 22, 2021

Package DI Number

18809315679883

Quantity per Package

20

Contains DI Package

08809315679886

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box