Bionova® - "Self-contained Biological Indicator for - TERRAGENE S.A.

Duns Number:970856911

Device Description: "Self-contained Biological Indicator for monitoring hydrogen peroxide sterilization proces "Self-contained Biological Indicator for monitoring hydrogen peroxide sterilization processes"

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More Product Details

Catalog Number

-

Brand Name

Bionova®

Version/Model Number

BT96

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

FRC

Product Code Name

Indicator, Biological Sterilization Process

Device Record Status

Public Device Record Key

b5a9a4d8-3859-47b4-a07e-2b66d42e7d30

Public Version Date

January 18, 2021

Public Version Number

1

DI Record Publish Date

January 08, 2021

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