| Primary Device ID | 00810032660116 |
| NIH Device Record Key | 7ae352b8-446b-4c37-b15e-a2fbe1b969ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zyris, Isolite Mouthpiece |
| Version Model Number | CIL0601 |
| Catalog Number | CIL0601 |
| 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 |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00810032660116 [Primary] |
| GS1 | 10810032660113 [Unit of Use] |
| DYN | Mouthpiece, saliva ejector |
| EIF | ACCESSORIES, RETRACTOR, DENTAL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
[00810032660116]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-02 |
| Device Publish Date | 2019-09-24 |
| 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 |