Maxso M200E

GUDID 00628504370155

M200E-M/M4, M4 Backend, Single Spray, Non-Optic

Beyes Dental Canada Inc

Dental power tool system handpiece, pneumatic

• Primary Device ID: 00628504370155
• NIH Device Record Key: f74fc8e7-812a-437f-80e1-52bae4d46e75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maxso M200E
• Version Model Number: HP2105
• Company DUNS: 244261462
• Company Name: Beyes Dental Canada 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628504370155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101551

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[00628504370155]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-22
• Device Publish Date: 2019-04-12

Devices Manufactured by Beyes Dental Canada Inc

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• 00990010306653 - Comfort-Sonic: 2024-01-29 Woodpecker: GC1 , Quickly removes obstructions and broken instruments in the middle and apical thirds of large and straight cana
• 00990010306660 - Comfort-Sonic: 2024-01-29 Woodpecker: GC2, Removal of supragingival calculus, interdental calculus and calculus at the neck of the teeth