VenaCure
GUDID 15051684015134
VenaCure 1470 Laser
ANGIODYNAMICS, INC.
General/multiple surgical diode laser system| Primary Device ID | 15051684015134 |
| NIH Device Record Key | e0dad55a-beea-4ed5-af2f-45735ef29061 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VenaCure |
| Version Model Number | VCURE1470/US |
| Company DUNS | 079105071 |
| Company Name | ANGIODYNAMICS, INC. |
| 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 | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com | |
| Phone | +1(518)795-1676 |
| dgreer@angiodynamics.com |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 500 KiloPascal and 1014 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 55 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051684015134 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110225
FDA Product Code
| GEX | Powered laser surgical instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-10 |
| Device Publish Date | 2024-01-02 |
On-Brand Devices [VenaCure]
| H787165100010 | Venacure EVLT NeverTouch Direct Introducer Sheath |
| 15051684015134 | VenaCure 1470 Laser |
Trademark Results [VenaCure]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VENACURE 76578978 3068771 Live/Registered |
AngioDynamics, Inc. 2004-03-03 |
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