Catalog Number

73041-

Brand Name

Kendall SCD

Version/Model Number

73041

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

-

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Public Device Record Key

b3b95db7-8f96-4b96-9489-96176897ac0a

Public Version Date

February 25, 2021

Public Version Number

1

DI Record Publish Date

February 17, 2021

Package DI Number

50192253016060

Quantity per Package

5

Contains DI Package

10192253016062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE