US Handpiece, Standard

GUDID 00850039020087

Medical Technical Products, Inc.

Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece Phacoemulsification system handpiece

• Primary Device ID: 00850039020087
• NIH Device Record Key: 7c61c10d-ce82-4c68-85cd-c4115bcf7b7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: US Handpiece, Standard
• Version Model Number: 01-899145
• 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: 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

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	00850039020087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940088

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

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

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

[00850039020087]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-23
• Device Publish Date: 2023-02-15

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