Propper PASS/FAIL Steam Challenge Pack - PASS/FAIL® Challenge Pack - Steam Pack with Type - PROPPER MANUFACTURING COMPANY, INC.

Duns Number:001483130

Device Description: PASS/FAIL® Challenge Pack - Steam Pack with Type 5 Integrator - 20 test packs per case

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More Product Details

Catalog Number

26906200

Brand Name

Propper PASS/FAIL Steam Challenge Pack

Version/Model Number

26906200

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

K991276,K991276

Product Code Details

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Device Record Status

Public Device Record Key

e556512f-499a-4dd1-b8e8-9c3af3f15d8e

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

October 23, 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