Catalog Number

-

Brand Name

DJO Global DVT Sleeve

Version/Model Number

RM-3046

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

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

K121145,K121145

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

c0a0202a-7d34-48e5-b277-51fd00aaf2e2

Public Version Date

August 02, 2019

Public Version Number

4

DI Record Publish Date

August 23, 2016

Package DI Number

10816317020030

Quantity per Package

20

Contains DI Package

00816317020033

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE