Primary Device ID | H862TIVH202 |
NIH Device Record Key | 0a7e60da-1f27-4448-aa29-3842d57221ae |
Commercial Distribution Discontinuation | 2019-09-17 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Tru-Incise Valvulotome with Interchangeable Heads |
Version Model Number | TIVH20 |
Catalog Number | TIVH20 |
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 |
Outer Diameter | 2 Micrometer |
Device Issuing Agency | Device ID |
---|---|
HIBCC | H862TIVH200 [Primary] |
HIBCC | H862TIVH201 [Package] Contains: H862TIVH200 Package: Dispenser [1 Units] Discontinued: 2019-09-17 Not in Commercial Distribution |
HIBCC | H862TIVH202 [Package] Contains: H862TIVH201 Package: Shipper [10 Units] Discontinued: 2019-09-17 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 | 2019-09-18 |
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 |