Zyris, Isodry EID0101

GUDID 00810032660260

System, Isodry

ZYRIS, INC.

Dental suction system

• Primary Device ID: 00810032660260
• NIH Device Record Key: 5348f96f-a91f-4289-b8ee-2cc5bfd78aa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zyris, Isodry
• Version Model Number: EID0101
• Catalog Number: EID0101
• 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
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810032660260 [Primary]

FDA Product Code

• EBR: UNIT, SUCTION OPERATORY

Sterilization

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

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

[00810032660260]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-02
• Device Publish Date: 2019-09-24

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• 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