| Primary Device ID | 00810000526697 |
| NIH Device Record Key | 34496d7c-0593-4b97-9f98-7157e86cced0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 20/20™ |
| Version Model Number | S575 |
| Catalog Number | S575 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, INC. |
| Device Count | 6 |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com | |
| Phone | 6312491134 |
| customerservice@parkell.com |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Clean Ultrasonically. Do Not use Dry Heat for sterilization. Do Not subject mirrors to temperatures above 180C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Clean Ultrasonically. Do Not use Dry Heat for sterilization. Do Not subject mirrors to temperatures above 180C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Clean Ultrasonically. Do Not use Dry Heat for sterilization. Do Not subject mirrors to temperatures above 180C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Clean Ultrasonically. Do Not use Dry Heat for sterilization. Do Not subject mirrors to temperatures above 180C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Clean Ultrasonically. Do Not use Dry Heat for sterilization. Do Not subject mirrors to temperatures above 180C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Clean Ultrasonically. Do Not use Dry Heat for sterilization. Do Not subject mirrors to temperatures above 180C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Clean Ultrasonically. Do Not use Dry Heat for sterilization. Do Not subject mirrors to temperatures above 180C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Clean Ultrasonically. Do Not use Dry Heat for sterilization. Do Not subject mirrors to temperatures above 180C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Clean Ultrasonically. Do Not use Dry Heat for sterilization. Do Not subject mirrors to temperatures above 180C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Clean Ultrasonically. Do Not use Dry Heat for sterilization. Do Not subject mirrors to temperatures above 180C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Clean Ultrasonically. Do Not use Dry Heat for sterilization. Do Not subject mirrors to temperatures above 180C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Clean Ultrasonically. Do Not use Dry Heat for sterilization. Do Not subject mirrors to temperatures above 180C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do Not Clean Ultrasonically. Do Not use Dry Heat for sterilization. Do Not subject mirrors to temperatures above 180C. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000526697 [Unit of Use] |
| GS1 | 10810000526694 [Primary] |
| EAX | Mirror, Mouth |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810000526697]
Moist Heat or Steam Sterilization
[00810000526697]
Moist Heat or Steam Sterilization
[00810000526697]
Moist Heat or Steam Sterilization
[00810000526697]
Moist Heat or Steam Sterilization
[00810000526697]
Moist Heat or Steam Sterilization
[00810000526697]
Moist Heat or Steam Sterilization
[00810000526697]
Moist Heat or Steam Sterilization
[00810000526697]
Moist Heat or Steam Sterilization
[00810000526697]
Moist Heat or Steam Sterilization
[00810000526697]
Moist Heat or Steam Sterilization
[00810000526697]
Moist Heat or Steam Sterilization
[00810000526697]
Moist Heat or Steam Sterilization
[00810000526697]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-10-06 |
| Device Publish Date | 2025-09-26 |
| 10810000527585 | 20/20™ Double Sided Mouth Mirrors (Pkg. of 6 pcs.) |
| 00810000526697 | 20/20™ Double Sided Mouth Mirrors (Pkg. of 6 pcs.) |
Mark Image Registration | Serial | Company Trademark Application Date |
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Jobson Medical Information LLC 2017-07-10 |
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Performance Support Systems, Inc. 2015-10-16 |
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ASHLAND LICENSING & INTELLECTUAL PROPERTY LLC 2013-09-04 |
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PRO GLASS ALLIANCE, LLC 2013-04-01 |
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Summit Electric Supply Company, Inc. 2012-02-15 |