Isolite, i2 PIL0213

GUDID 00810032660758

Isolite 2 ; Isodry Anterior Adapter Kit

ZYRIS, INC.

Dental suction system

• Primary Device ID: 00810032660758
• NIH Device Record Key: 12bf143e-8e8b-4b84-add5-6e4d829a7eb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isolite, i2
• Version Model Number: PIL0213
• Catalog Number: PIL0213
• 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	00810032660758 [Primary]

FDA Product Code

• EBR: UNIT, SUCTION OPERATORY

Sterilization

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

[00810032660758]

Moist Heat or Steam Sterilization

[00810032660758]

Moist Heat or Steam Sterilization

[00810032660758]

Moist Heat or Steam Sterilization

[00810032660758]

Moist Heat or Steam Sterilization

[00810032660758]

Moist Heat or Steam Sterilization

[00810032660758]

Moist Heat or Steam Sterilization

[00810032660758]

Moist Heat or Steam Sterilization

[00810032660758]

Moist Heat or Steam Sterilization

[00810032660758]

Moist Heat or Steam Sterilization

[00810032660758]

Moist Heat or Steam Sterilization

[00810032660758]

Moist Heat or Steam Sterilization

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, i2]

• 00810032660758: Isolite 2 ; Isodry Anterior Adapter Kit
• 00810032660734: Power Adaptor, 5VDC-1Amp, Grey
• 00810032660710: Vacuum Lever Set
• 00810032660703: Vacuum Light Pipe