M3 Printer 9A401001

GUDID 00841709100192

The M9 printer is optimal for mechanical monitoring of each cycle. Records and prints critical sterilization cycle data, including chamber temperature and pressure, cycle elapsed times, and program cycle type.

MIDMARK CORPORATION

Ink printer

• Primary Device ID: 00841709100192
• NIH Device Record Key: 9b94a499-c53a-4d8f-87e3-70f989415997
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M3 Printer
• Version Model Number: 9A401001
• Catalog Number: 9A401001
• Company DUNS: 005036025
• Company Name: MIDMARK CORPORATION
• 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: true
• 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: true

Customer Support Contacts

• Phone: 1-(800)634-6289
• Email: telemarketing@midmark.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841709100192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090670

FDA Product Code

• FLE: Sterilizer, Steam

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: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by MIDMARK CORPORATION

• 00841709121326 - Midmark: 2024-04-30 Midmark Smart G-Vacuums are intended to provide suction during general examinations and procedures conducted by qualified dental
• 00841709121333 - Midmark: 2024-04-30 Midmark Smart G-Vacuums are intended to provide suction during general examinations and procedures conducted by qualified dental
• 00841709121340 - Midmark: 2024-04-30 Midmark Smart G-Vacuums are intended to provide suction during general examinations and procedures conducted by qualified dental
• 00841709121357 - Midmark: 2024-04-30 Midmark Smart G-Vacuums are intended to provide suction during general examinations and procedures conducted by qualified dental
• 00841709121364 - Midmark: 2024-04-30 Midmark Smart G-Vacuums are intended to provide suction during general examinations and procedures conducted by qualified dental
• 00841709121371 - Midmark: 2024-04-30 Midmark Smart G-Vacuums are intended to provide suction during general examinations and procedures conducted by qualified dental
• 00841709121388 - Midmark: 2024-04-30 Smart G-Vacuum-Base unit assembly, 1500 RPM and 3-5 users, used on the G3-050, G6-050 Smart G-Vacuums.
• 00841709121395 - Midmark: 2024-04-30 Smart G-Vacuum Base unit assembly, 1725 RPM and 5-7 users, used on the G5-010, G10-050 Smart G-Vacuums.