Catalog Number

-

Brand Name

Sklar®

Version/Model Number

10-1131

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K890759

Product Code

JOJ

Product Code Name

Indicator, physical/chemical sterilization process

Public Device Record Key

00d82852-c917-4c82-af73-a72472721e0f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 23, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-