Glo Science

Basic Information

• Brand Name: Glo Science
• Primary DI: 18600033217209
• Version / Model: 6HPGT
• Company Name: ORTHOFX
• Labeler DUNS: 033755180
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-18
• Public Version: 3
• Public Version Date: 2020-11-27
• Public Version Status: Update
• Public Device Record Key: e03403be-15ca-4f2b-8ae0-331ea02704ee
• Distribution End Date: 2020-11-27

Device Description

Over the counter teeth whitening gel

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: Yes
• Has Serial Number: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
46432	Teeth whitening kit	A collection of devices intended to whiten natural teeth through bleaching. It typically includes a bleaching agent (e.g., a gel containing a low concentration of an oxidizing agent, such as carbamide peroxide or hydrogen peroxide), a syringe(s), a tray(s), a mouthguard, an applicator (e.g., a brush) and strips to apply/retain the bleaching agent to/on the teeth for a recommended period. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18600033217209	GS1

Customer Contacts

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