Isolite, i3 PIL0304

GUDID 00810032660789

Adaptor, Power, 12VDC-1Amp, i3

ZYRIS, INC.

Dental suction system

• Primary Device ID: 00810032660789
• NIH Device Record Key: 0b51d67a-8b69-42db-a5dc-9cc3143760ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isolite, i3
• Version Model Number: PIL0304
• Catalog Number: PIL0304
• 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	00810032660789 [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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• 00810032660901: Power Adaptor, EU, 4.5m, i3
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• 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
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