Zyris, Isolite Mouthpiece CIL0701

GUDID 00810032660147

Mouthpiece, 10-Pack, Medium

ZYRIS, INC.

Hand-held dental retractor

• Primary Device ID: 00810032660147
• NIH Device Record Key: f46e0fe3-0720-4c9e-b905-47b12ec653e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zyris, Isolite Mouthpiece
• Version Model Number: CIL0701
• Catalog Number: CIL0701
• Company DUNS: 068038277
• Company Name: ZYRIS, INC.
• Device Count: 10
• 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	00810032660147 [Primary]
GS1	10810032660144 [Unit of Use]

FDA Product Code

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

Sterilization

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

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

Moist Heat or Steam Sterilization

[00810032660147]

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, Isolite Mouthpiece]

• 00810032660253: Mouthpiece, Bulk (100), Extra Small
• 00810032660246: Mouthpiece, Bulk (144), Extra Small
• 00810032660239: Mouthpiece, 10-Pack, Extra Small
• 00810032660222: Mouthpiece, Bulk (100), Large
• 00810032660215: Mouthpiece, Bulk (144), Large
• 00810032660208: Mouthpiece, 10-Pack, Large
• 00810032660192: Mouthpiece, Bulk (100), Medium DV
• 00810032660185: Mouthpiece, Bulk (144), Medium DV
• 00810032660178: Mouthpiece, 10-Pack, Medium DV
• 00810032660161: Mouthpiece, Bulk (100), Medium
• 00810032660154: Mouthpiece, Bulk (144), Medium
• 00810032660147: Mouthpiece, 10-Pack, Medium
• 00810032660130: Mouthpiece, Bulk (100), Small
• 00810032660123: Mouthpiece, Bulk (144), Small
• 00810032660116: Mouthpiece, 10-Pack, Small
• 00810032660109: Mouthpiece, Bulk (100), Pediatric
• 00810032660093: Mouthpiece, Bulk (144), Pediatric
• 00810032660086: Mouthpiece, 10-Pack, Pediatric
• 00810032660079: Mouthpiece, 10-Pack, Original Large
• 00810032660062: Mouthpiece, Bulk (144), Original Medium
• 00810032660055: Mouthpiece, 10-Pack, Original Medium
• 00810032660048: Mouthpiece, Bulk (144), Original Small
• 00810032660031: Mouthpiece, 10-Pack, Original Small
• 00810032660024: Mouthpiece, Bulk (100), Original Pediatric
• 00810032660017: Mouthpiece, Bulk (144), Original Pediatric
• 00810032660000: Mouthpiece, 10-Pack, Original Pediatric