Vozzle 0600-1222-000

GUDID 10817984010331

Vozzle Vacu-Irrigator DS

MECTRA LABS, INC.

Surgical irrigation/aspiration system

• Primary Device ID: 10817984010331
• NIH Device Record Key: 2e009acc-872c-4b25-9187-67eff82af518
• Commercial Distribution Discontinuation: 2020-01-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vozzle
• Version Model Number: 0600-1222-000
• Catalog Number: 0600-1222-000
• Company DUNS: 606939072
• Company Name: MECTRA LABS, 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com
• Phone: +1(800)323-3968
• Email: mectrasales@mectralabs.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit
• Handling Environment Temperature: Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817984010334 [Primary]
GS1	10817984010331 [Package]; Contains: 00817984010334; Package: Inner pack [10 Units]; Discontinued: 2020-01-10; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895756

FDA Product Code

• GBX: CATHETER, IRRIGATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-01-13
• Device Publish Date: 2019-01-29

On-Brand Devices [Vozzle]

• 10817984010331: Vozzle Vacu-Irrigator DS
• 10817984010324: Vozzle Vacu-Irrigator SS