Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V HC 80TT-120-001

GUDID 00850012210009

STERILUCENT, INC.

Hydrogen peroxide gas sterilizer

• Primary Device ID: 00850012210009
• NIH Device Record Key: f88961c0-953f-452c-aaf7-010ac999ee6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V
• Version Model Number: HC 80TT-120-001
• Catalog Number: HC 80TT-120-001
• Company DUNS: 005634969
• Company Name: STERILUCENT, INC.
• Device Count: 1
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-877-721-8405
• Email: CustomerService@Sterilucent.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012210009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190005

FDA Product Code

• MLR: Sterilizer, Chemical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-04-28

Devices Manufactured by STERILUCENT, INC.

• 00850012210030 - Sterilucent™ Sterilant Disc: 2020-05-07
• 00850012210054 - Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen Cycle: 2020-05-07
• 00850012210078 - Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle: 2020-05-07
• 00850012210009 - Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V: 2020-05-06
• 00850012210009 - Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V: 2020-05-06