Catalog Number

210SAL

Brand Name

Kendall

Version/Model Number

210SAL

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K083042,K083042

Product Code

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

8f3d1e8e-3f5d-42f0-9f99-b6b6f07a8311

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 22, 2018

Package DI Number

10884521139756

Quantity per Package

12

Contains DI Package

20884521139753

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE