Isodry PID101

GUDID 00810032661021

Titanium Control Base, Isodry

ZYRIS, INC.

Dental suction system

• Primary Device ID: 00810032661021
• NIH Device Record Key: 95f8e109-8793-464e-8713-1ba07d3c306e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isodry
• Version Model Number: PID0101
• Catalog Number: PID101
• 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: false
• Serial Number: true
• 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	00810032661021 [Primary]

FDA Product Code

• EBR: UNIT, SUCTION OPERATORY

Sterilization

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

[00810032661021]

Moist Heat or Steam Sterilization

[00810032661021]

Moist Heat or Steam Sterilization

[00810032661021]

Moist Heat or Steam Sterilization

[00810032661021]

Moist Heat or Steam Sterilization

[00810032661021]

Moist Heat or Steam Sterilization

[00810032661021]

Moist Heat or Steam Sterilization

[00810032661021]

Moist Heat or Steam Sterilization

[00810032661021]

Moist Heat or Steam Sterilization

[00810032661021]

Moist Heat or Steam Sterilization

[00810032661021]

Moist Heat or Steam Sterilization

[00810032661021]

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

Devices Manufactured by ZYRIS, INC.

• 00810032661250 - Isolite Mouthpiece: 2024-05-10 Customer Success Kit, OUS
• 10810032661233 - Hoopla Retractor: 2024-05-03 Hoopla Retractor, Small, 40-Pack
• 10810032661240 - Hoopla Retractor: 2024-05-03 Hoopla Retractor, Small, 80-Pack
• 00810032660703 - Isolite, i2: 2024-04-29 Vacuum Light Pipe
• 00810032660710 - Isolite, i2: 2024-04-29 Vacuum Lever Set
• 00810032660734 - Isolite, i2: 2024-04-29 Power Adaptor, 5VDC-1Amp, Grey
• 00810032660758 - Isolite, i2: 2024-04-29 Isolite 2 ; Isodry Anterior Adapter Kit
• 00810032660765 - Isolite, i3: 2024-04-29 Control Head Hose, i3