| Primary Device ID | H862TIVK20302 |
| NIH Device Record Key | 906d4822-827a-45c5-a770-aa1d51ba5eeb |
| Commercial Distribution Discontinuation | 2019-09-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Tru-Incise Valvulotome with Interchangeable Heads |
| Version Model Number | TIVK2030 |
| Catalog Number | TIVK2030 |
| Company DUNS | 192559557 |
| Company Name | URESIL, LLC |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-538-7374 |
| sales@uresil.com |
| Length | 94 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H862TIVK20300 [Primary] |
| HIBCC | H862TIVK20301 [Package] Contains: H862TIVK20300 Package: Dispenser [1 Units] Discontinued: 2019-09-11 Not in Commercial Distribution |
| HIBCC | H862TIVK20302 [Package] Contains: H862TIVK20301 Package: Shipper [10 Units] Discontinued: 2019-09-11 Not in Commercial Distribution |
| MGZ | Valvulotome |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-09-12 |
| Device Publish Date | 2016-08-31 |
| H862TIVH302 | Tru-Incise 3mm Cutting Head |
| H862TIVH202 | Tru-Incise 2mm Cutting Head |
| H862TIVC2 | Tru-Incise Valvulotome Catheter Kit |
| H862TIVH40NC2 | Tru-Incise 4mm Cutting Head |
| H862TIVH30NC2 | Tru-Incise 3mm Cutting Head |
| H862TIVH20NC2 | Tru-Incise 2mm Cutting Head |
| H862TIVCNC2 | Tru-Incise Valvulotome Catheter Kit |
| H862TIVK2030NC2 | Tru-Incise Valvulotome |
| H862TIVK20302 | Tru-Incise Valvulotome |
| H862TIVH402 | Tru-Incise 4mm Cutting Head |