Catalog Number

1233LF

Brand Name

Comply™

Version/Model Number

1233LF

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

K093199,K093199,K093199

Product Code

JOJ

Product Code Name

Indicator, physical/chemical sterilization process

Public Device Record Key

a2a92755-bfcf-4c25-b102-fc36160247e7

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

50707387584158

Quantity per Package

5

Contains DI Package

30707387584154

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX