Isolite, i3 PIL0311

GUDID 00810032660840

Adaptor, Power, 12VDC-1Amp, 15ft, i3

ZYRIS, INC.

Dental suction system Dental suction system Dental suction system Dental suction system Dental suction system Dental suction system Dental suction system Dental suction system Dental suction system Dental suction system Dental suction system

• Primary Device ID: 00810032660840
• NIH Device Record Key: 8701899e-7528-48ab-9aef-ba1c9e797908
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isolite, i3
• Version Model Number: PIL0311
• Catalog Number: PIL0311
• 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	00810032660840 [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

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• 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