Henry Schein Maxima 1125542

GUDID 00304040057995

Maxima T-Style Motor

HENRY SCHEIN, INC.

Dental power tool system handpiece, pneumatic

• Primary Device ID: 00304040057995
• NIH Device Record Key: f07f9273-288f-4cbc-a157-ed6cb32bbcb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Henry Schein Maxima
• Version Model Number: 1125542
• Catalog Number: 1125542
• 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	00304040057995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073652

FDA Product Code

• EFB: Handpiece, air-powered, dental

Sterilization

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

[00304040057995]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-04
• Device Publish Date: 2019-11-26

On-Brand Devices [Henry Schein Maxima]

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• 20304040030718: Maxima Gold Diamond FGSS
• 20304040030701: MAXIMA GOLD Diamond FG
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• 20304040030688: MAXIMA GOLD Diamond FG
• 20304040030671: MAXIMA GOLD Diamond FG