Tuttnauer® - Unique point Integrator Indicator for Steam - TERRAGENE S.A.

Duns Number:970856911

Device Description: Unique point Integrator Indicator for Steam sterilization processes.

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More Product Details

Catalog Number

-

Brand Name

Tuttnauer®

Version/Model Number

WTL198-0068

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Device Record Status

Public Device Record Key

fe47d43e-a7a5-4430-b609-d4d5b41923a5

Public Version Date

April 01, 2022

Public Version Number

1

DI Record Publish Date

March 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TERRAGENE S.A." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 81