DualMode 20744
GUDID 07898961835068
DualMode
VYDENCE MEDICAL
Dermatological laser beam guiding handpiece| Primary Device ID | 07898961835068 |
| NIH Device Record Key | f0d6afef-c63b-4850-ad6b-206a83660612 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DualMode |
| Version Model Number | 20744 |
| Catalog Number | 20744 |
| Company DUNS | 904013281 |
| Company Name | VYDENCE MEDICAL |
| Device Count | 1 |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com | |
| Phone | +551633065050 |
| sac@vydence.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07898961835068 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171443
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
[07898961835068]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-04 |
| Device Publish Date | 2024-05-27 |
Devices Manufactured by VYDENCE MEDICAL
| 07898961835426 - handPICO | 2025-01-29 HandPICO |
| 07898961835013 - ETHEREA-MX | 2024-06-04 ETHEREA-MX |
| 07898961835020 - IPL-Sq | 2024-06-04 IPL-Sq |
| 07898961835037 - LongPulse | 2024-06-04 LongPulse |
| 07898961835044 - ProDeep | 2024-06-04 ProDeep |
| 07898961835051 - GoSmooth | 2024-06-04 GoSmooth |
| 07898961835068 - DualMode | 2024-06-04DualMode |
| 07898961835068 - DualMode | 2024-06-04 DualMode |
| 07898961835082 - SIBERIAN-FIT | 2024-06-04 SIBERIAN-FIT |
Trademark Results [DualMode]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DUALMODE 97820378 not registered Live/Pending |
Stathera Inc. 2023-03-02 |
 DUALMODE 88981686 not registered Live/Pending |
Crown Equipment Corporation 2018-08-30 |
 DUALMODE 88975128 5921127 Live/Registered |
Crown Equipment Corporation 2018-08-30 |
 DUALMODE 88975127 5870327 Live/Registered |
Crown Equipment Corporation 2018-08-30 |
 DUALMODE 88099724 not registered Live/Pending |
Crown Equipment Corporation 2018-08-30 |
 DUALMODE 88099687 not registered Live/Pending |
Crown Equipment Corporation 2018-08-30 |
 DUALMODE 87590200 not registered Dead/Abandoned |
Dewesoft d.o.o. 2017-08-30 |
 DUALMODE 75050276 2051708 Dead/Cancelled |
Northern Telecom Limited 1996-01-30 |
 DUALMODE 74027609 not registered Dead/Abandoned |
Northern Telecom Limited 1990-02-12 |
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