20/20™ S475
GUDID 10810000527585
20/20™ Double Sided Mouth Mirrors (Pkg. of 6 pcs.)
PARKELL, INC.
Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable Dental mirror, reusable| Primary Device ID | 10810000527585 |
| NIH Device Record Key | 98cda766-62c2-41a8-980c-2a005b51b32c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 20/20™ |
| Version Model Number | S475 |
| Catalog Number | S475 |
| 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 |
Customer Support Contacts
| 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 | |
| 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 |
Operating and Storage Conditions
| 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. |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000527588 [Unit of Use] |
| GS1 | 10810000527585 [Primary] |
FDA Product Code
| EAX | Mirror, Mouth |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
[10810000527585]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-01-29 |
| Device Publish Date | 2019-08-30 |
Devices Manufactured by PARKELL, INC.
| 10810000525086 - Dryz™ | 2024-04-03 Dryz™ Syringe Gingival Hemostatic Retraction Paste (Pkg. of 7 Syringes) |
| 00810000525720 - HyperFIL® | 2024-03-11 Hyperfil® 3ml Universal Shade |
| 00810000525737 - HyperFIL® | 2024-03-11 Hyperfil® 3ml Enamel Shade |
| 10810000527585 - 20/20™ | 2024-01-2920/20™ Double Sided Mouth Mirrors (Pkg. of 6 pcs.) |
| 10810000527585 - 20/20™ | 2024-01-29 20/20™ Double Sided Mouth Mirrors (Pkg. of 6 pcs.) |
| 10810000524409 - Cinch™ | 2024-01-26 Cinch® Plus Ultra-Light Wash (2-Cartridges & Tips) |
| 10810000524416 - Cinch™ | 2024-01-26 Quick Cinch® Plus Ultra-Light Wash (2-Cartridges & Tips) |
| 10810000524133 - Mach-2® | 2024-01-25 Mach-2® Die Silicone |
| 10810000524157 - Blu-Mousse® | 2024-01-25 Peppermint Classic Blu-Mousse® In Split-Cartridge System |
Trademark Results [20/20]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 20/20 98157766 not registered Live/Pending |
Veriphy Inc 2023-08-30 |
 20/20 90196808 not registered Live/Pending |
20/20 Company 2020-09-21 |
 20/20 90148497 not registered Live/Pending |
RT RECOVER INNOVATIONS LTD 2020-08-31 |
 20/20 88380297 not registered Live/Pending |
20/20 Company 2019-04-10 |
 20/20 88107448 not registered Live/Pending |
Thor-lo, Inc. 2018-09-06 |
 20/20 87755296 not registered Dead/Abandoned |
20/20 IP LLC 2018-01-15 |
 20/20 87655457 not registered Live/Pending |
Jobson Medical Information LLC 2017-10-23 |
 20/20 87522139 5406224 Live/Registered |
Jobson Medical Information LLC 2017-07-10 |
 20/20 86790405 not registered Dead/Abandoned |
Performance Support Systems, Inc. 2015-10-16 |
 20/20 86055696 4736017 Live/Registered |
ASHLAND LICENSING & INTELLECTUAL PROPERTY LLC 2013-09-04 |
 20/20 85892291 not registered Dead/Abandoned |
PRO GLASS ALLIANCE, LLC 2013-04-01 |
 20/20 85543262 4300285 Live/Registered |
Summit Electric Supply Company, Inc. 2012-02-15 |
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