FDA.reportPublic FDA data

Tru-Incise Valvulotome with Interchangeable Heads

Primary DI
H862TIVH200
Brand
Tru-Incise Valvulotome with Interchangeable Heads
Company
URESIL, LLC
Model
TIVH20
Catalog number
TIVH20
Device description
Tru-Incise 2mm Cutting Head
Published
2016-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGZValvulotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGZValvulotomeCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930011000URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADSUresil Corp.1993-05-26MGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H862TIVH201PackageHIBCC1Not in Commercial Distribution
H862TIVH202PackageHIBCC10Not in Commercial Distribution
H862TIVH200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vein stripper, single-useA sterile hand-held surgical instrument designed to manually excise (strip by stab avulsion) a length or section of a vein from a patient, typically varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is typically designed as: 1) a flexible stainless steel cable with a stripping cup or disk (commonly known as an olive) attached to one end, and a handle at the other (some types can employ a guide tip); or 2) a rigid or semi-rigid rod terminating in a closed ring or loop (also known as a ring stripper). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2Micrometer

Contacts#

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

Regulatory Flags#

DUNS number
192559557
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00817640020387Nephro-Stent Nephroureteral Stent CatheterNSL2-0822HNSL2-0822H2022-04-29
00817640020394Nephro-Stent Nephroureteral Stent CatheterNSL2-0824HNSL2-0824H2022-04-29
00817640020400Nephro-Stent Nephroureteral Stent CatheterNSL2-0826HNSL2-0826H2022-04-29
00817640020417Nephro-Stent Nephroureteral Stent CatheterNSL2-0828HNSL2-0828H2022-04-29
00817640020424Nephro-Stent Nephroureteral Stent CatheterNSL2-1022HNSL2-1022H2022-04-29
00817640020431Nephro-Stent Nephroureteral Stent CatheterNSL2-1024HNSL2-1024H2022-04-29
00817640020448Nephro-Stent Nephroureteral Stent CatheterNSL2-1026HNSL2-1026H2022-04-29
00817640020455Nephro-Stent Nephroureteral Stent CatheterNSL2-1028HNSL2-1028H2022-04-29
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
00817640020462Thora-Vent Thoracic VentOTW11-13OTW11-132022-06-02
H862TFK060Tru-Fix Catheter Fixation KitTFK-06TFK-062016-08-31
H862TFK080Tru-Fix Catheter Fixation KitTFK-08TFK-082016-08-31
H862TFK100Tru-Fix Catheter Fixation KitTFK-10TFK-102016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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 Valvulotome Lemaitre Vascular, Inc.MGZ2022-06-30
H862TIVCNC0Tru-Incise Valvulotome with Interchangeable HeadsURESIL, LLCMGZ2019-09-17
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
00846159010978SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159010985SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159010992SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159031997SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02
00846159032000SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INCMGZ2016-09-02