Galaxy

GUDID 00190730009722

Galaxy 7901 Debonding Bur-Short Flame 12 Fluted High Speed 5/PK

ORTHO TECHNOLOGY, INC.

Carbide dental bur, reusable

• Primary Device ID: 00190730009722
• NIH Device Record Key: dd551611-44a5-4f92-bd93-3d2ca18381e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Galaxy
• Version Model Number: 7901OT
• 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	00190730009722 [Primary]

FDA Product Code

• EJL: BUR, 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: 3
• Public Version Date: 2020-03-23
• Device Publish Date: 2018-02-20

On-Brand Devices [Galaxy]

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• 00190730009791: Perforated Strips Narrow Fine 10/pk 2.5mm wide 30 micron
• 00190730009784: Perforated Strips Narrow Med 10/pk 2.5mm wide 45 micron
• 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
• 00190730009722: Galaxy 7901 Debonding Bur-Short Flame 12 Fluted High Speed 5/PK
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