Catalog Number

9789R

Brand Name

Kendall SCD

Version/Model Number

9789R

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

f3f8781d-f14e-457d-b676-d84be66e3830

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

20884521213620

Quantity per Package

5

Contains DI Package

10884521213623

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE