Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle SL291

GUDID 00850012210078

STERILUCENT, INC.

Biological sterilization indicator

• Primary Device ID: 00850012210078
• NIH Device Record Key: 3711cb71-a485-46dc-9273-e7951ee92d84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle
• Version Model Number: SL291
• Catalog Number: SL291
• Company DUNS: 005634969
• Company Name: STERILUCENT, INC.
• Device Count: 25
• 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

• Special Storage Condition, Specify: Between 0 and 0 *• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012210078 [Unit of Use]
GS1	00850012210085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192001

FDA Product Code

• FRC: Indicator, Biological Sterilization Process

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
• 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
• 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