Bionova® - Steam Test Pack PCD Kit (25 test packs and 25 - TERRAGENE S.A.

Duns Number:970856911

Device Description: Steam Test Pack PCD Kit (25 test packs and 25 control BIs)

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More Product Details

Catalog Number

-

Brand Name

Bionova®

Version/Model Number

KPCD224-2

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

88252d82-7c2c-4769-acec-d680c2f16fca

Public Version Date

March 29, 2022

Public Version Number

1

DI Record Publish Date

March 21, 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