Catalog Number

73043

Brand Name

Kendall SCD

Version/Model Number

73043

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 01, 2023

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

-

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Public Device Record Key

ee1533ae-a2db-47cb-9622-dffea96c5bab

Public Version Date

January 06, 2021

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

40884521052216

Quantity per Package

3

Contains DI Package

30884521052219

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

CASE