Propper PASS/FAIL Steam Challenge Pack 26906200

GUDID 70818087012057

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

PROPPER MANUFACTURING COMPANY, INC.

Chemical/physical sterilization process indicator

• Primary Device ID: 70818087012057
• NIH Device Record Key: e556512f-499a-4dd1-b8e8-9c3af3f15d8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Propper PASS/FAIL Steam Challenge Pack
• Version Model Number: 26906200
• Catalog Number: 26906200
• Company DUNS: 001483130
• Company Name: PROPPER MANUFACTURING COMPANY, INC.
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818087012055 [Unit of Use]
GS1	70818087012057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991276

FDA Product Code

• JOJ: Indicator, Physical/Chemical Sterilization Process

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-23

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