Isolite, i2 PIL0205

GUDID 00810032660710

Vacuum Lever Set

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: 00810032660710
• NIH Device Record Key: 1e1f8cf4-3268-41be-ad6f-ffe0e49463cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isolite, i2
• Version Model Number: PIL0205
• Catalog Number: PIL0205
• 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	00810032660710 [Primary]

FDA Product Code

• EAZ: LIGHT, OPERATING, DENTAL

Sterilization

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

[00810032660710]

Moist Heat or Steam Sterilization

[00810032660710]

Moist Heat or Steam Sterilization

[00810032660710]

Moist Heat or Steam Sterilization

[00810032660710]

Moist Heat or Steam Sterilization

[00810032660710]

Moist Heat or Steam Sterilization

[00810032660710]

Moist Heat or Steam Sterilization

[00810032660710]

Moist Heat or Steam Sterilization

[00810032660710]

Moist Heat or Steam Sterilization

[00810032660710]

Moist Heat or Steam Sterilization

[00810032660710]

Moist Heat or Steam Sterilization

[00810032660710]

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