Galaxy

GUDID 00190730030702

Galaxy Interproximal Reduction 6pc Gauge Set

ORTHO TECHNOLOGY, INC.

Interproximal dental gauge, reusable

• Primary Device ID: 00190730030702
• NIH Device Record Key: c4a8ca66-2d3f-4ce5-a998-0342f3e98852
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Galaxy
• Version Model Number: IPR-GAUGE
• Company DUNS: 781772017
• Company Name: ORTHO TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• 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: 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	00190730030702 [Primary]

FDA Product Code

• EIL: GAUGE, DEPTH, INSTRUMENT, DENTAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-08-09
• Device Publish Date: 2019-05-14

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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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• 00190730030702: Galaxy Interproximal Reduction 6pc Gauge Set