FDA.reportPublic FDA data

SCANLAN® Vascular Tunneler

Primary DI
00846159036459
Brand
SCANLAN® Vascular Tunneler
Company
SCANLAN INTERNATIONAL INC
Model
9009-02T
Catalog number
9009-02T
Device description
Replacement Tip for SCANLAN® Sartor Tunneler 9009-02
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846159036459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846159036459008461590364598461590364590846159036459

GMDN Terms#

Term, Definition table
TermDefinition
Vascular graft tunnellerA long, surgical instrument used to tunnel an artificial passageway along vascular tissue planes to create a connecting channel typically for the introduction of a vascular graft or a vascular prosthesis. It can have a variety of designs, but basically it will be a long, round, stiff rod that tapers to a rounded point at the distal tip and have a handle at the proximal end to allow the surgeon to exert the necessary pressure and manipulation to push it through the body tissue. It will typically be made of high-grade stainless steel and possibly other materials for the handle, which may be detachable. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
651-298-0997vanderpoelw@scanlangroup.com

Regulatory Flags#

DUNS number
023055619
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00846159036411SCANLAN® Clamp3785-443785-442026-09-21
00846159036428SCANLAN® Clamp3786-443786-442026-09-21
00846159040845SCANLAN® ScissorsQ32034Q320342026-08-26
00846159040852SCANLAN® ScissorsQ32035Q320352026-08-26
00846159040869SCANLAN® ScissorsQ32046Q320462026-08-26
00846159040678SCANLAN® Minimally-Invasive InstrumentationQ29142-9Q29142-92026-07-17
00846159040685SCANLAN Minimally-Invasive InstrumentationQ29150-9Q29150-92026-07-17
00846159040692SCANLAN Minimally-Invasive InstrumentationQ29163-9Q29163-92026-07-17
00846159040708SCANLAN®9009-941P9009-941P2026-07-17
00846159036152SCANLAN® Bulldog Clamp3795-453795-452026-06-23
00846159036404SCANLAN® Bulldog Clamp3795-553795-552026-06-09
00846159040524SCANLAN® Retractor8008-568008-562026-06-04
00846159040531SCANLAN® Retractor8008-598008-592026-06-04
00846159040548SCANLAN® Retractor8008-608008-602026-06-04
00846159040555SCANLAN® Retractor8888-058888-052026-06-04
00846159040562SCANLAN® Retractor8888-588888-582026-06-04
00846159040579SCANLAN® Retractor8989-188989-182026-06-04
00846159040586SCANLAN® RetractorQ195Q1952026-06-04
00846159040593SCANLAN® RetractorQ219Q2192026-06-04
00846159040609SCANLAN® RetractorQ222Q2222026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661219527688DELACROIX-CHEVALIERLANDANGERDWS2026-09-27
00724995286651V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286668V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286675V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286682V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
10884389855416NAMICMEDLINE INDUSTRIES, INC.DWS2026-09-25
04058749012446NAFehling Instruments GmbH & Co. KGDWS2026-09-21
00192896123762TAVR Removal SetSONTEC INSTRUMENTS, INC.DWS2026-09-18
B040PHR10Premature Hinged Sternal RetractorGENESEE BIOMEDICAL, INC.DWS2026-09-18
00190776429119MillenniumAvalign Technologies, Inc.DWS2026-09-04
00884450456217Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456224Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456231Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
04058749008944NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749012521NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749036350NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749122626NAFehling Instruments GmbH & Co. KGDWS2026-09-04
00190776423933MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776423971MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424114MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424138MillenniumAvalign Technologies, Inc.DWS2026-08-27
00884450450970Merit Medical®Merit Medical Systems, Inc.DWS2026-08-27
00190776419707MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420284MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420390MillenniumAvalign Technologies, Inc.DWS2026-08-25
04058749004496NAFehling Instruments GmbH & Co. KGDWS2026-08-25
00190776417130MillenniumAvalign Technologies, Inc.DWS2026-08-19
00190776416973MillenniumAvalign Technologies, Inc.DWS2026-08-18
00190776417000MillenniumAvalign Technologies, Inc.DWS2026-08-18
00198506094064ELMED INCORPORATEDELMED INCORPORATEDDWS2026-08-18