Sterilucent™ Sterilant Disc SL001, SL279

GUDID 00850012210030

STERILUCENT, INC.

Hydrogen peroxide device sterilant

• Primary Device ID: 00850012210030
• NIH Device Record Key: a714ddaf-d8f5-4e72-b1ec-c2aebf0d800c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilucent™ Sterilant Disc
• Version Model Number: SL001
• Catalog Number: SL001, SL279
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012210023 [Primary]
GS1	00850012210030 [Package]; Contains: 00850012210023; Package: 5-Pack REF SL001 [5 Units]; In Commercial Distribution
GS1	00850012210047 [Package]; Package: Case REF SL279 [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140464

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: 2020-05-07
• Device Publish Date: 2020-04-29

Devices Manufactured by STERILUCENT, INC.

• 00850012210030 - Sterilucent™ Sterilant Disc: 2020-05-07
• 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