PolyVue
GUDID 08806392050096
INTEROJO INC.
Soft corrective contact lens, daily-wear| Primary Device ID | 08806392050096 |
| NIH Device Record Key | d6dd45d0-a6a9-4fd1-8758-713dd5561ef9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PolyVue |
| Version Model Number | HD pro color/Amethyst |
| Company DUNS | 688455799 |
| Company Name | INTEROJO INC. |
| Device Count | 2 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com | |
| Phone | +1-760-754-2220 |
| rho@interojo.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806392050003 [Primary] |
| GS1 | 08806392050096 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K020608
FDA Product Code
| LPL | Lenses, Soft Contact, Daily Wear |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-21 |
| Device Publish Date | 2020-08-13 |
On-Brand Devices [PolyVue]
| 08806392051123 | HDX Progressive |
| 08806392050171 | HD pro color/Turquoise |
| 08806392050164 | HD pro color/True Sapphire |
| 08806392050157 | HD pro color/Pure Hazel |
| 08806392050140 | HD pro color/Honey |
| 08806392050133 | HD pro color/HAZEL |
| 08806392050126 | HD pro color/GREEN |
| 08806392050119 | HD pro color/GRAY |
| 08806392050102 | HD pro color/Brown |
| 08806392050096 | HD pro color/Amethyst |
| 08806392051116 | High Definition |
| 08800190057301 | HD pro color/Zombie Red |
| 08800190057295 | HD pro color/Wild Fire |
| 08800190057288 | HD pro color/Red Cat |
| 08809867730349 | HD pro color /Yellow Cat |
| 08809867730325 | HD pro color /Zombie Black |
| 08800143688910 | HD pro color/White Out |
| 08809901666757 | Clalen / -06.00 |
| 08809901666740 | Clalen / -04.00 |
| 08809901666733 | Clalen / +02.75 |
Trademark Results [PolyVue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLYVUE 75285755 not registered Dead/Abandoned |
INNOTECH, INC. 1997-05-02 |
 POLYVUE 75269661 2152326 Dead/Cancelled |
DUNN, STEPHEN A. 1997-04-04 |
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