Operators Manual, M2000, Premium

GUDID 00850039020377

Medical Technical Products, Inc.

Phacoemulsification system

• Primary Device ID: 00850039020377
• NIH Device Record Key: 9edcedb6-efab-4c6a-9330-26a56754158e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Operators Manual, M2000, Premium
• Version Model Number: 75-9003
• Company DUNS: 151291010
• Company Name: Medical Technical Products, 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: false
• 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

Customer Support Contacts

• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com
• Phone: +1(949)551-4762
• Email: service@medtechprods.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850039020377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940084

FDA Product Code

• HQC: Unit, Phacofragmentation

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: 2023-02-22
• Device Publish Date: 2023-02-14

Devices Manufactured by Medical Technical Products, Inc.

• 00850039020001 - Console, M2000, Value: 2023-02-23
• 00850039020018 - Console, M2000, Enhanced: 2023-02-23
• 00850039020025 - Console, M2000, Premium: 2023-02-23
• 00850039020032 - Footpedal, M2000, Herga: 2023-02-23
• 00850039020049 - Footpedal, M2000, MTP: 2023-02-23
• 00850039020056 - Console, M3000: 2023-02-23
• 00850039020063 - IV Pole Cart, M3000: 2023-02-23
• 00850039020070 - Footpedal, M3000, MTP: 2023-02-23