Zyris, Isodry EID0101

GUDID 00810032660260

System, Isodry

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 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: 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

Devices Manufactured by ZYRIS, INC.

• 00810032660321 - Zyris: 2024-04-16 Isovac2, Single
• 10810032660335 - Zyris: 2024-04-16 Isovac2, 3-Pack
• 10810032660342 - Zyris: 2024-04-16 Anterior Mouthpiece, 10-Pack, Small
• 10810032660359 - Zyris: 2024-04-16 Anterior Mouthpiece, 10-Pack, Medium
• 10810032660366 - Zyris: 2024-04-16 Anterior Mouthpiece, 10-Pack, Large
• 10810032660373 - Zyris: 2024-04-16 Anterior Mouthpiece, 100-Pack, Small
• 10810032660380 - Zyris: 2024-04-16 Anterior Mouthpiece, 100-Pack, Medium
• 10810032660397 - Zyris: 2024-04-16 Anterior Mouthpiece, 100-Pack, Large