MST/Sonata Tip 0.7mm Reverse Bevel, Single PT-35030-R-1

GUDID 00844685005413

MICROSURGICAL TECHNOLOGY, INC.

Phacoemulsification system handpiece tip, reusable

• Primary Device ID: 00844685005413
• NIH Device Record Key: 58b4706d-bd82-42a1-b1f5-b5a0e1f54441
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MST/Sonata Tip 0.7mm Reverse Bevel, Single
• Version Model Number: PT-35030-R-1
• Catalog Number: PT-35030-R-1
• Company DUNS: 097824130
• Company Name: MICROSURGICAL TECHNOLOGY, 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844685005413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943672

FDA Product Code

• HQC: Unit, Phacofragmentation

Sterilization

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

[00844685005413]

Moist Heat or Steam Sterilization;Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-08

On-Brand Devices [MST/Sonata Tip 0.7mm Reverse Bevel, Single]

• 00844685005413: PT-35030-R-1
• 00844685005406: PT-36030-GRN-1
• 00844685005390: PT-36030-Y-1