VenaCure EVLT
GUDID H787114030130
NeverTouch FRS 65cm Procedure Kit
ANGIODYNAMICS, INC.
Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit Varicose vein lasing procedure kit| Primary Device ID | H787114030130 |
| NIH Device Record Key | 4b5fa00e-c619-4868-90c2-b340d9d58ea8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VenaCure EVLT |
| Version Model Number | 11403013 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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(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 | |
| 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 |
Device Dimensions
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
| Length | 65 Centimeter |
| Needle Gauge | 21 Gauge |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 27 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051684014564 [Secondary] |
| HIBCC | H787114030130 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K112600
FDA Product Code
| GEX | Powered laser surgical instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-25 |
| Device Publish Date | 2016-09-20 |
On-Brand Devices [VenaCure EVLT]
| H787EVLTPVAK0 | VenaCure 400 Micron Fiber Procedure Kit |
| H787EVLT80OPS0 | VenaCure 80cm Procedure Kit w/ Spotlight OPS Sheath |
| H787EVLT55OPS0 | VenaCure 55cm Procedure Kit w/ Spotlight OPS Sheath, 1 Fiber w/ SMA Connector |
| H787EVLT25OPS0 | VenaCure 25cm Procedure Kit w/ Spotlight OPS Sheath, 1 Fiber w/ SMA Connector |
| H787114033015 | VenaCure Tre-Sheath Set |
| H787514030100 | NeverTouch FRS 65cm Procedure Kit |
| H787514030090 | NeverTouch FRS 45cm Procedure Kit |
| H787514030080 | NeverTouch FRS 25cm Procedure Kit |
| H787514030070 | NeverTouch FRS 65cm Procedure Kit |
| H787514030050 | NeverTouch FRS 65cm Procedure Kit |
| H787514030020 | NeverTouch FRS 65cm Procedure Kit |
| H787514030010 | NeverTouch FRS 45cm Procedure Kit |
| H787114030130 | NeverTouch FRS 65cm Procedure Kit |
| H787114030120 | NeverTouch FRS 45cm Procedure Kit |
| H787114030070 | NeverTouch FRS 90cm Procedure Kit |
| H787114030060 | NeverTouch FRS 65cm Procedure Kit |
| H787114030050 | NeverTouch FRS 45cm Procedure Kit |
| H787114030040 | NeverTouch FRS 90cm Procedure Kit |
| H787114030030 | NeverTouch FRS 25cm Procedure Kit |
| H787114030020 | NeverTouch FRS 65cm Procedure Kit |
| H787114030010 | NeverTouch FRS 45cm Procedure Kit |
| H787EVLTPVAKUS0 | VenaCure 400 Micron Perforator and Accessory Vein Ablation Kit |
| H787514020080 | NeverTouch 65cm Procedure Kit |
| H787514020070 | NeverTouch 45cm Procedure Kit |
| H787514020060 | NeverTouch 65cm Procedure Kit |
| H787514020050 | NeverTouch 45cm Procedure Kit |
| H787114033025 | VenaCure Tre-Sheath Set |
| H787114031015 | NeverTouch Direct Procedure Kit, 1 Fiber w/ SMA 905 Connector |
| H787114020020 | NeverTouch 65cm Procedure Kit |
| H787114020010 | NeverTouch 45cm Procedure Kit |
| 15051684020848 | VenaCure OPS 55cm EVLT Fiber |
Trademark Results [VenaCure EVLT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VENACURE EVLT 77594562 3857464 Live/Registered |
ANGIODYNAMICS, INC. 2008-10-16 |
 VENACURE EVLT 77594542 3857463 Live/Registered |
ANGIODYNAMICS, INC. 2008-10-16 |
 VENACURE EVLT 77594460 3857462 Live/Registered |
ANGIODYNAMICS, INC. 2008-10-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.