Catalog Number

-

Brand Name

Sklar®

Version/Model Number

10-1624

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"

Yes

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

-

Product Code

MED

Product Code Name

Sterilant, medical devices

Public Device Record Key

e9ff3c83-cafe-41c5-9802-2c612788613a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 21, 2016

Package DI Number

50649111358553

Quantity per Package

4

Contains DI Package

10649111358692

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-