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Propper PASS/FAIL Steam Challenge Pack

FDA UDI

Class II (US FDA UDI)

by Propper Manufacturing Co., Inc.

Identity

Trade Name
Propper PASS/FAIL Steam Challenge Pack FDA UDI
Generic Name
Chemical/physical sterilization process indicator FDA UDI
Device Name
PASS/FAIL® Challenge Pack - Steam Pack with Type 5 Integrator - 20 test packs per case FDA UDI
Model / Reference
26906200 FDA UDI
Description
PASS/FAIL® Challenge Pack - Steam Pack with Type 5 Integrator - 20 test packs per case FDA UDI

Identifiers

Catalog Number
26906200 FDA UDI
Primary DI / UDI-DI
70818087012057 FDA UDI
510(k) Number
K991276 FDA UDI
FDA Product Code
JOJ FDA UDI
GMDN Term
Chemical/physical sterilization process indicator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Chemical/physical sterilization process indicator

Propper PASS/FAIL Steam Challenge Pack by Propper Manufacturing Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chemical/physical sterilization process indicator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI e556512f-499a-4dd1-b8e8-9c3af3f15d8e 35 fields · synced May 29, 2026