Zyris, Isolite Mouthpiece CIL0302

GUDID 00810032660062

Mouthpiece, Bulk (144), Original Medium

ZYRIS, INC.

Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor Hand-held dental retractor

• Primary Device ID: 00810032660062
• NIH Device Record Key: fe063a56-c90d-475a-b3fe-387f3a8f8e85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zyris, Isolite Mouthpiece
• Version Model Number: CIL0302
• Catalog Number: CIL0302
• Company DUNS: 068038277
• Company Name: ZYRIS, INC.
• Device Count: 144
• 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: true
• 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 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810032660062 [Primary]
GS1	10810032660069 [Unit of Use]

FDA Product Code

• DYN: Mouthpiece, saliva ejector
• EIF: ACCESSORIES, RETRACTOR, DENTAL

Sterilization

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

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

Moist Heat or Steam Sterilization

[00810032660062]

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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• 00810032660024: Mouthpiece, Bulk (100), Original Pediatric
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