Galaxy™

GUDID 00190730085689

Perforated Strips Wide Ex.Fine 10/pk 3.75mm wide 15 micron

ORTHO TECHNOLOGY, INC.

Dental abrasive strip, single-use

• Primary Device ID: 00190730085689
• NIH Device Record Key: 231b0143-16fe-4389-9ff4-034fcb305e55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Galaxy™
• Version Model Number: 88503
• Company DUNS: 781772017
• Company Name: ORTHO TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190730085689 [Primary]

FDA Product Code

• EHM: STRIP, POLISHING AGENT

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: 2021-09-29
• Device Publish Date: 2021-09-21

On-Brand Devices [Galaxy™]

• 00190730086150: High Shine Enamel Polisher 3/bag Friction Grip
• 00190730086143: High Shine Enamel Polisher 3/bag Latch Shank
• 00190730086136: Terminator Metal Cutter 5/pk High Speed
• 00190730086112: High Speed Burs Intro Kit 14 burs/bur block
• 00190730086105: High Speed IPR Kit 10 pc Bur Block
• 00190730086099: Debonding-Long Flame 5/pk High Speed
• 00190730086082: Debonding-Long Flame 12 Fluted 5/pk Low Speed
• 00190730086075: Debonding Lingual-Football 5/pk High Speed
• 00190730086068: Debonding Lingual-Football 12 Fluted 5/pk Low Speed
• 00190730086051: Debonding-Long Taper 5/pk High Speed
• 00190730086044: Debonding-Long Taper 12 Fluted 5/pk Low Speed
• 00190730086020: Debonding Carbides 218 18 Fluted/High Speed 5/pk
• 00190730086013: Debonding Carbide 5/pk 10 Fluted/High Speed
• 00190730086006: Debonding Carbides 118S 18 Fluted/High Speed 5/pk
• 00190730085993: Debonding Carbides 118L 18 Fluted/High Speed 5/pk
• 00190730085948: Debonding Polisher 6.5mm head, White 3/pk Latch Shank
• 00190730085931: Debonding Polisher 7.5mm head, White 3/pk Latch Shank
• 00190730085924: Debonding Polisher 9.0mm head, White 3/pk Latch Shank
• 00190730085917: Diamond Discs 19mm Intro Kit 3 Discs/Bur Block
• 00190730085900: Diamond Discs 22mm Intro Kit 4 Discs/Bur Block
• 00190730085894: Diamond Discs Intro Kit 3 discs/bur block
• 00190730085887: Debonding Burs Intro Kit 8 burs/bur block
• 00190730085870: Mesh Diamond Disc 19mm 2 Discs/pk with Mandrel
• 00190730085863: Mesh Diamond Disc 22mm 2 Discs/pk with Mandrel
• 00190730085856: See-Thru Diamond Disc 22mm 2 Discs/pk with Mandrel
• 00190730085849: Diamond Disc Double Sided 19mm 2 Discs/pk with Mandrel
• 00190730085832: Diamond Disc Single Sided 19mm 2 Discs/pk with Mandrel
• 00190730085825: Diamond Disc Single Sided 22mm 2 Discs/pk with Mandrel
• 00190730085818: Diamond Disc Double Sided 22mm 2 Discs/pk with Mandrel
• 00190730085801: Interproximal Diamond-Fine 5/pk High Speed
• 00190730085795: Shorter IPR Stripping Diamonds: 5/pk Fine
• 00190730085788: Interproximal Diamond-Medium 5/pk High Speed
• 00190730085771: Shorter IPR Stripping Diamonds: 5/pk-Medium
• 00190730085764: Mosquito IPR Stripping Diamonds: 5/pk-Fine
• 00190730085726: Perforated Strip Narrow ExFine 10/pk 2.5mm wide 15 micron
• 00190730085719: Perforated Strips Narrow Fine 10/pk 2.5mm wide 30 micron
• 00190730085702: Perforated Strips Narrow Med 10/pk 2.5mm wide 45 micron
• 00190730085696: Perforated Strips Narrow Kit 9/pk 3 each type 2.5mm wide
• 00190730085689: Perforated Strips Wide Ex.Fine 10/pk 3.75mm wide 15 micron
• 00190730085672: Perforated Strips Wide Fine 10/pk 3.75mm wide 30 micron
• 00190730085665: Perforated Strips Wide Med 10/pk 3.75mm wide 45 micron
• 00190730085658: Perforated Strips Wide Kit 9/pk 3 each type 3.75mm wide