Catalog Number

KEN9529

Brand Name

NA

Version/Model Number

KEN9529

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

K012597,K012597

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Public Device Record Key

b3bea3f1-b609-4eb0-b0bd-d3c22d1e1065

Public Version Date

August 14, 2019

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

20888551042694

Quantity per Package

5

Contains DI Package

10888551042697

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton