Galaxy™

Basic Information

• Brand Name: Galaxy™
• Primary DI: 00190707192532
• Version / Model: G634
• Company Name: Ortho Organizers, Inc.
• Labeler DUNS: 062165188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2025-10-23
• Public Version: 3
• Public Version Date: 2025-12-30
• Public Version Status: Update
• Public Device Record Key: cea5f564-3ad2-4af0-bbc3-149fddd298a1

Device Description

GALAXY Acrylic Polishers 6/pk Dark Blue-Coarse Grit max rpm 10,000

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHM	STRIP, POLISHING AGENT	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35702	Dental abrasive strip, single-use	A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10190707192539	GS1
Primary	00190707192532	GS1