Isolite, i3 PIL0315

GUDID 00810032660888

Accessory Kit, Dentsply Sirona

ZYRIS, INC.

Dental suction system

• Primary Device ID: 00810032660888
• NIH Device Record Key: 90f3c3e8-3c52-4773-a6ed-32c99dea14f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isolite, i3
• Version Model Number: PIL0315
• Catalog Number: PIL0315
• Company DUNS: 068038277
• Company Name: ZYRIS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• 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)560-6066
• Email: regulatory@zyris.com
• Phone: +1(800)560-6066
• Email: regulatory@zyris.com
• Phone: +1(800)560-6066
• Email: regulatory@zyris.com
• Phone: +1(800)560-6066
• Email: regulatory@zyris.com
• Phone: +1(800)560-6066
• Email: regulatory@zyris.com
• Phone: +1(800)560-6066
• Email: regulatory@zyris.com
• Phone: +1(800)560-6066
• Email: regulatory@zyris.com
• Phone: +1(800)560-6066
• Email: regulatory@zyris.com
• Phone: +1(800)560-6066
• Email: regulatory@zyris.com
• Phone: +1(800)560-6066
• Email: regulatory@zyris.com
• Phone: +1(800)560-6066
• Email: regulatory@zyris.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810032660888 [Primary]

FDA Product Code

• EAZ: LIGHT, OPERATING, DENTAL

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: 2024-04-29
• Device Publish Date: 2024-04-19

On-Brand Devices [Isolite, i3]

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• 00810032660956: Vacuum Light Pipe, Si, i3
• 00810032660949: 0.25 BSP Spiral Fitting
• 00810032660932: Power Vacuum Base, OUS, i3
• 00810032660925: Power Adaptor, AUS, 4.5m, i3
• 00810032660901: Power Adaptor, EU, 4.5m, i3
• 00810032660888: Accessory Kit, Dentsply Sirona
• 00810032660871: Sirona Suction Port, Teneo
• 00810032660864: Sirona Suction Port, Intego
• 00810032660857: Power Cable Extension Cord, 30cm
• 00810032660840: Adaptor, Power, 12VDC-1Amp, 15ft, i3
• 00810032660833: Cleaning Tip, Re-circulation, i3
• 00810032660826: Barb Fitting, 10.5mm, i3
• 00810032660819: Cleaning Tip, i3
• 00810032660802: Vacuum Lever Set, i3
• 00810032660796: Power Terminal Cable, i3
• 00810032660789: Adaptor, Power, 12VDC-1Amp, i3
• 00810032660772: Power Vacuum Base, i3
• 00810032660765: Control Head Hose, i3