VenaCure EVLT
GUDID H787114030130
NeverTouch FRS 65cm Procedure Kit
ANGIODYNAMICS, INC.
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 |
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