Catalog Number

CI0BI25

Brand Name

Crosstex International

Version/Model Number

CI0BI25

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

K023716,K023716,K023716

Product Code

FRC

Product Code Name

Indicator, biological sterilization process

Public Device Record Key

64db9287-efff-4721-aa9e-d67b4b433b62

Public Version Date

April 13, 2020

Public Version Number

2

DI Record Publish Date

September 04, 2019

Package DI Number

50732224000461

Quantity per Package

4

Contains DI Package

10732224000463

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case