ProChek ID - Steam Sterilization Indicator Tape - CERTOL INTERNATIONAL, LLC

Duns Number:095153714

Device Description: Steam Sterilization Indicator Tape

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More Product Details

Catalog Number

PIT100-1

Brand Name

ProChek ID

Version/Model Number

PIT100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

K951113,K951113

Product Code Details

Product Code

LRT

Product Code Name

Indicator, Sterilization

Device Record Status

Public Device Record Key

0f47492f-43fc-4cc2-ba72-2c7e468fcdae

Public Version Date

November 01, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

H816PIT1002

Quantity per Package

6

Contains DI Package

H816PIT1001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Box

"CERTOL INTERNATIONAL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2