Tru-Incise Valvulotome with Interchangeable Heads TIVH30

GUDID H862TIVH302

Tru-Incise 3mm Cutting Head

URESIL, LLC

Vein stripper, single-use
Primary Device IDH862TIVH302
NIH Device Record Keyfd6d83a8-85c8-4391-a99e-99e3a4930334
Commercial Distribution Discontinuation2019-09-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameTru-Incise Valvulotome with Interchangeable Heads
Version Model NumberTIVH30
Catalog NumberTIVH30
Company DUNS192559557
Company NameURESIL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-538-7374
Emailsales@uresil.com

Device Dimensions

Outer Diameter3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH862TIVH300 [Primary]
HIBCCH862TIVH301 [Package]
Contains: H862TIVH300
Package: Dispenser [1 Units]
Discontinued: 2019-09-17
Not in Commercial Distribution
HIBCCH862TIVH302 [Package]
Contains: H862TIVH301
Package: Shipper [10 Units]
Discontinued: 2019-09-17
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MGZValvulotome

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-18
Device Publish Date2016-08-31

On-Brand Devices [Tru-Incise Valvulotome with Interchangeable Heads]

H862TIVH302Tru-Incise 3mm Cutting Head
H862TIVH202Tru-Incise 2mm Cutting Head
H862TIVC2Tru-Incise Valvulotome Catheter Kit
H862TIVH40NC2Tru-Incise 4mm Cutting Head
H862TIVH30NC2Tru-Incise 3mm Cutting Head
H862TIVH20NC2Tru-Incise 2mm Cutting Head
H862TIVCNC2Tru-Incise Valvulotome Catheter Kit
H862TIVK2030NC2Tru-Incise Valvulotome
H862TIVK20302Tru-Incise Valvulotome
H862TIVH402Tru-Incise 4mm Cutting Head

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