Propper Duo-Record Steam & Ethylene Oxide Record Keeping Cards - Duo-Record® Steam & Ethylene Oxide Record Keeping - PROPPER MANUFACTURING COMPANY, INC.

Duns Number:001483130

Device Description: Duo-Record® Steam & Ethylene Oxide Record Keeping Cards - 1 Box of 250 Cards

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More Product Details

Catalog Number

26905200

Brand Name

Propper Duo-Record Steam & Ethylene Oxide Record Keeping Cards

Version/Model Number

26905200

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

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Device Record Status

Public Device Record Key

e772b5c8-2da9-423d-a4dc-9a8435abcbe4

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 17, 2017

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