Galaxy

GUDID 00190730009739

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

ORTHO TECHNOLOGY, INC.

Dental abrasive strip, reusable

• Primary Device ID: 00190730009739
• NIH Device Record Key: ad01f40b-164e-4d1f-a712-03889c3ec2e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Galaxy
• Version Model Number: 88500
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00190730009739 [Primary]

FDA Product Code

• EHM: STRIP, POLISHING AGENT

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-23
• Device Publish Date: 2018-02-20

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• 00190730009777: Perforated Strips Narrow Kit 9/pk 3 each type 2.5mm wide
• 00190730009760: Perforated Strips Wide Ex.Fine 10/pk 3.75mm wide 15 micron
• 00190730009753: Perforated Strips Wide Fine 10/pk 3.75mm wide 30 micron
• 00190730009746: Perforated Strips Wide Med 10/pk 3.75mm wide 45 micron
• 00190730009739: Perforated Strips Wide Kit 9/pk 3 each type 3.75mm wide
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