SurgiPro 5701730

GUDID 00304040125670

Air Powered Highspeed Surgical Handpiece

HENRY SCHEIN, INC.

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• Primary Device ID: 00304040125670
• NIH Device Record Key: cb9d2f8c-31ed-4434-8843-709b98d0f1ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgiPro
• Version Model Number: 5701730
• Catalog Number: 5701730
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• 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	00304040125670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190508

FDA Product Code

• EFB: Handpiece, air-powered, dental

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: 2020-02-10
• Device Publish Date: 2020-01-31

On-Brand Devices [SurgiPro]

• 00304040125687: Air Powered Highspeed Surgical Handpiece
• 00304040125670: Air Powered Highspeed Surgical Handpiece
• 00304040125663: Air Powered Highspeed Surgical Handpiece