Catalog Number

TSI440-1

Brand Name

ProChek S

Version/Model Number

TSI440

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K060103,K060103,K060103

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

3b1218ae-67d4-4117-8ea3-20048ce13f42

Public Version Date

November 01, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

H816TSI4402

Quantity per Package

6

Contains DI Package

H816TSI4401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-