Catalog Number

MDS630BD

Brand Name

N/A

Version/Model Number

N/A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 06, 2021

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

K060091,K060091

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Public Device Record Key

c7d71806-aee0-452e-be62-4ecc09d22b26

Public Version Date

February 08, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

50885825017472

Quantity per Package

10

Contains DI Package

00885825017477

Package Discontinue Date

February 06, 2021

Package Status

Not in Commercial Distribution

Package Type

case