Venclose™ EVSRF™ Catheter
GUDID 00858254006176
Endovenous Radiofrequency Ablation (RFA) Catheter, 100cm, 5 pack
VENCLOSE INC
Radio-frequency ablation system| Primary Device ID | 00858254006176 |
| NIH Device Record Key | ba669deb-2b8b-4433-9e75-49e57f49993a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Venclose™ EVSRF™ Catheter |
| Version Model Number | VC-10A2.5-6F-100 [5X] |
| Company DUNS | 085838983 |
| Company Name | VENCLOSE INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
Device Dimensions
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
| Length | 100 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858254006176 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160754
FDA Product Code
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-01 |
On-Brand Devices [Venclose™ EVSRF™ Catheter]
| 00858254006190 | Endovenous Radiofrequency Ablation (RFA) Catheter, 100cm, 10 pack |
| 00858254006183 | Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm, 10 pack |
| 00858254006176 | Endovenous Radiofrequency Ablation (RFA) Catheter, 100cm, 5 pack |
| 00858254006169 | Endovenous Radiofrequency Ablation (RFA) Catheter, 60cm, 5 pack |
Trademark Results [Venclose]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VENCLOSE 87777079 5584380 Live/Registered |
Venclose, Inc. 2018-01-30 |
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