Catalog Number

SCW2

Brand Name

Crosstex International

Version/Model Number

SCW2

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

-

Product Code

KCT

Product Code Name

Sterilization wrap containers, trays, cassettes & other accessories

Public Device Record Key

dd9af1e4-8756-40a5-9424-b00365cc9c21

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

November 11, 2016

Package DI Number

50732224110467

Quantity per Package

20

Contains DI Package

10732224110469

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case