Galaxy

Basic Information

• Brand Name: Galaxy
• Primary DI: 00190730009739
• Version / Model: 88500
• Company Name: ORTHO TECHNOLOGY, INC.
• Labeler DUNS: 781772017
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-20
• Public Version: 5
• Public Version Date: 2021-09-21
• Public Version Status: Update
• Public Device Record Key: ad01f40b-164e-4d1f-a712-03889c3ec2e1
• Distribution End Date: 2021-09-20

Device Description

Perforated Strips Wide Kit 9/pk 3 each type 3.75mm wide

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
63358	Dental abrasive strip, reusable	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 (e.g., polishing, finishing, contouring, reducing) the surface of a tooth or restoration during a dental procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190730009739	GS1