Sterilucent™ Sterilant Disc

Basic Information

• Brand Name: Sterilucent™ Sterilant Disc
• Primary DI: 00850012210023
• Version / Model: SL001
• Catalog Number: SL001, SL279
• Company Name: STERILUCENT, INC.
• Labeler DUNS: 005634969
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-29
• Public Version: 1
• Public Version Date: 2020-05-07
• Public Version Status: New
• Public Device Record Key: a714ddaf-d8f5-4e72-b1ec-c2aebf0d800c

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MLR	Sterilizer, Chemical	General Hospital	880.6860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44835	Hydrogen peroxide device sterilant	A gaseous or liquid substance that includes hydrogen peroxide (H2O2) as its primary agent to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. The substance may be presented in discrete quantities to accommodate the requirements of a sterilization device or system. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850012210030	GS1	5-Pack REF SL001	5	In Commercial Distribution
Primary	00850012210023	GS1
Package	00850012210047	GS1	Case REF SL279	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140464	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 86 Degrees Fahrenheit