Zyris, Isovac EIV0106

GUDID 00810032660314

Isovac, EDU, 2-Pack, UCLA

ZYRIS, INC.

Dental suction system

• Primary Device ID: 00810032660314
• NIH Device Record Key: 30356074-444b-4a61-a90b-182ba53ca776
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zyris, Isovac
• Version Model Number: EIV0106
• Catalog Number: EIV0106
• Company DUNS: 068038277
• Company Name: ZYRIS, INC.
• Device Count: 2
• 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
• 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	00810032660314 [Primary]
GS1	10810032660311 [Unit of Use]

FDA Product Code

• EBR: UNIT, SUCTION OPERATORY

Sterilization

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

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

Moist Heat or Steam Sterilization

[00810032660314]

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

On-Brand Devices [Zyris, Isovac]

• 00810032660314: Isovac, EDU, 2-Pack, UCLA
• 00810032660307: Isovac, Three Pack
• 00810032660291: Isovac, Single