SteriScan 4400

GUDID 50724995152272

The SteriScan Extended Cycle Tube is a single-use plastic tube that is designed to hold a biological indicator in place during the steam sterilization

STERIS CORPORATION

Chemical/physical sterilization process indicator

• Primary Device ID: 50724995152272
• NIH Device Record Key: d6486dee-cf7b-45e2-acb0-64b1baa1337c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriScan
• Version Model Number: 4400
• Catalog Number: 4400
• Company DUNS: 040469731
• Company Name: STERIS CORPORATION
• Device Count: 50
• 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: true

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995152277 [Unit of Use]
GS1	50724995152272 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103321

FDA Product Code

• FRC: Indicator, biological 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: 4
• Public Version Date: 2018-11-28
• Device Publish Date: 2016-09-13

On-Brand Devices [SteriScan]

• 00724995152260: The SteriScan Reusable Test Pack without counter and with 200 Six Steam Sterilization Emulators.
• 00724995152253: The SteriScan Reusable Test Pack with counter and 200 Six Steam Sterilization Emulators.
• 00724995152246: The SteriScan Reusable Test Pack without counter and with 200 Steam Sterilization Integrators.
• 00724995152239: The SteriScan Reusable Test Pack with counter includes 2 test packs with step counters, 200 VERI
• 00724995152222: The SteriScan Reusable Test Pack includes 2 test packs, 200 VERIFY STEAM Integrating Indicators
• 50724995152272: The SteriScan Extended Cycle Tube is a single-use plastic tube that is designed to hold a biolog
• 10724995152281: The SteriScan Bowie Dick Indicator is for exclusive use with the VERIFY All-In-One STEAM Reusabl
• 50724995152210: The SteriScan Six Steam Sterilization Emulator four-inch strip is for use in a variety of cycles
• 50724995152203: The SteriScan Six Steam Sterilization Emulator four-inch strip is for use in a variety of cycles
• 50724995152197: The SteriScan Steam Sterilization Integrator four-inch strip is for use in a variety of cycles a
• 50724995152180: The SteriScan Steam Sterilization Integrator four-inch strip is for use in a variety of cycles a