FDA.reportPublic FDA data

Tru-Incise Valvulotome with Interchangeable Heads

Primary DI
H862TIVCNC0
Brand
Tru-Incise Valvulotome with Interchangeable Heads
Company
URESIL, LLC
Model
TIVC
Catalog number
TIVC
Device description
Tru-Incise Valvulotome Catheter Kit
Published
2019-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGZValvulotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGZValvulotomeCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H862TIVCNC1PackageHIBCC1Not in Commercial Distribution
H862TIVCNC2PackageHIBCC10Not in Commercial Distribution
H862TIVCNC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Valvulotome, single-useA flexible tube with an exposable blade assembly at its distal end designed to incise/excise peripheral venous valves to allow retrograde flow of blood. It is introduced percutaneously over an in situ guidewire into a vein before being advanced distally to the valves, where the cutting implement is exposed using controls at the proximal end. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Contacts#

Phone, Email table
PhoneEmail
1-800-538-7374sales@uresil.com

Regulatory Flags#

DUNS number
192559557
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H862TIVH20NC0Tru-Incise Valvulotome with Interchangeable HeadsTIVH20TIVH202019-09-17
H862TIVH30NC0Tru-Incise Valvulotome with Interchangeable HeadsTIVH30TIVH302019-09-17
H862TIVH40NC0Tru-Incise Valvulotome with Interchangeable HeadsTIVH40TIVH402019-09-11
H862TIVK2030NC0Tru-Incise Valvulotome with Interchangeable HeadsTIVK2030TIVK20302019-09-11
H862TC6000Gravity Drainage BagTC600TC6002017-09-11
00817640020486Ulti-Flo General Purpose Drainage CatheterLBL2T-1430HBLBL2T-1430HB2022-04-27
00817640020493Ulti-Flo General Purpose Drainage CatheterLBL2T-1630HBLBL2T-1630HB2022-04-27
00817640020998GP General Purpose Drainage CatheterMPL2T-0625HMPL2T-0625H2022-04-27
00817640021339Ulti-Flo General Purpose Drainage CatheterLBL2-1430HBLBL2-1430HB2022-04-28
00817640021346Ulti-Flo General Purpose Drainage CatheterLBL2-1630HBLBL2-1630HB2022-04-28
00817640021643GP General Purpose Drainage CatheterGPL2T-0625HGPL2T-0625H2022-04-27
00817640020165Nephro-Stent Nephroureteral Stent CatheterNSL2T-0822HNSL2T-0822H2022-04-28
00817640020172Nephro-Stent Nephroureteral Stent CatheterNSL2T-0824HNSL2T-0824H2022-04-28
00817640020189Nephro-Stent Nephroureteral Stent CatheterNSL2T-0826HNSL2T-0826H2022-04-28
00817640020196Nephro-Stent Nephroureteral Stent CatheterNSL2T-0828HNSL2T-0828H2022-04-28
00817640020516Nephro-Stent Nephroureteral Stent CatheterNSL2T-1022HNSL2T-1022H2022-04-28
00817640020523Nephro-Stent Nephroureteral Stent CatheterNSL2T-1024HNSL2T-1024H2022-04-28
00817640020530Nephro-Stent Nephroureteral Stent CatheterNSL2T-1026HNSL2T-1026H2022-04-28
00817640020547Nephro-Stent Nephroureteral Stent CatheterNSL2T-1028HNSL2T-1028H2022-04-28
00817640020387Nephro-Stent Nephroureteral Stent CatheterNSL2-0822HNSL2-0822H2022-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD491118070Surgical DirectSurgical Direct, Inc.MGZ2026-10-22
00190776433796MillenniumAvalign Technologies, Inc.MGZ2026-10-08
00190776433802MillenniumAvalign Technologies, Inc.MGZ2026-10-08
00190776433819MillenniumAvalign Technologies, Inc.MGZ2026-10-08
B382SD4911930Surgical DirectSurgical Direct, Inc.MGZ2026-08-04
B382SD491118030Surgical DirectSurgical Direct, Inc.MGZ2026-08-04
00860013182304BoomerangAveera Medical Inc.MGZ2025-07-14
00860013182311BoomerangAveera Medical Inc.MGZ2025-07-14
00850041730134LimFlow VectorInari Medical, Inc.MGZ2024-04-12
00850041730028LimFlow VectorInari Medical, Inc.MGZ2023-06-26
00840663102297Eze-Sit ValvulotomeLemaitre Vascular, Inc.MGZ2022-06-30
H862TIVH20NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH30NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVCNC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH20NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH30NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
H862TIVH40NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
H862TIVK2030NC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
H862TIVK2030NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
H862TIVH40NC2Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-11
00887482049938Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482049945Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482049952Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482049969Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482090282Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
00887482090299Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.MGZ2018-09-25
M944AL103110Wexler Surgical, Inc.WEXLER SURGICAL, INC.MGZ2016-12-20
M944AL103010Wexler Surgical, Inc.WEXLER SURGICAL, INC.MGZ2016-12-19
04057034015308Valvulotome 25cm, blade 2mm, w/ballGeister Medizintechnik GmbHMGZ2016-09-21
04057034015322Valvulotome 23cm, blade 2mm, w/ballGeister Medizintechnik GmbHMGZ2016-09-21