Propper Duo-Spore Biological Indicator Growth Media Vials - Propper Duo-Spore Biological Indicator Growth - PROPPER MANUFACTURING COMPANY, INC.

Duns Number:001483130

Device Description: Propper Duo-Spore Biological Indicator Growth Media Vials (25/bx)

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More Product Details

Catalog Number

26910700

Brand Name

Propper Duo-Spore Biological Indicator Growth Media Vials

Version/Model Number

26910700

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)

-

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

6719064e-00dd-4d62-8f82-787ff365670b

Public Version Date

March 12, 2020

Public Version Number

1

DI Record Publish Date

March 04, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PROPPER MANUFACTURING COMPANY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 58
2 A medical device with a moderate to high risk that requires special controls. 49