FDA.reportPublic FDA data

Conductor

Primary DI
00814384020369
Brand
Conductor
Company
CONCERT MEDICAL, LLC
Model
EX
Catalog number
511920-001
Device description
Extension Guidewire
Published
2017-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814384020369PrimaryGS10
00814384020376Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814384020369008143840203698143840203690814384020369
00814384020376008143840203768143840203760814384020376

GMDN Terms#

Term, Definition table
TermDefinition
Coronary artery guidewire extensionA long, thin, sterile wire designed to provide the necessary length to allow the exchange of one coronary artery dilatation catheter for another, while maintaining the position of the cardiac catheter guidewire in the coronary artery, during angiography or percutaneous transluminal coronary angioplasty (PTCA). It is typically made of polymer-coated [e.g., polytetrafluoroethylene (PTFE)] stainless steel and supplied with a guidewire extension insertion device to facilitate its joining to the proximal end of the in situ guidewire. After the catheter exchange, the guidewire extension can be detached and the guidewire used as intended. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
189689800
Device count
5
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814384020437S-Wire Guidewire System511980-0012017-04-25
00814384020017GaleoHF4068862016-09-26
00814384020031GaleoF4068872016-09-26
00814384020055GaleoM4068882016-09-26
00814384020079GaleoES-F4068892016-09-26
00814384020093Galeo EWEW4068902016-09-26
00814384020116Galeo HYDROHF4068912016-09-26
00814384020130Galeo HYDROF4068922016-09-26
00814384020154Galeo HYDROM4068932016-09-26
00814384020178Galeo HYDROES-F4068942016-09-26
00814384020192Galeo ProHF3897812016-09-26
00814384020215Galeo ProF3897832016-09-26
00814384020239Galeo ProM3897852016-09-26
00814384020253Galeo ProES-F3897872016-09-26
00814384020277Galeo ProHF J3897822016-09-26
00814384020291Galeo ProF J3897842016-09-26
00814384020314Galeo ProM J3897862016-09-26
00814384020338Galeo ProES-F J3897882016-09-26
00814384020352Galeo Pro300 CM3897912016-09-26
00814384020383Hands Free SyringeHFS-SYR411987-0012017-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450589977SplashWire™Merit Medical Systems, Inc.DQX2026-06-02
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SADQX2026-03-02
07640142811305Guidewire 0.025 6/270cm angled Straub Medical AGDQX2022-06-30
07640142811312SET Aspirex™ S 6F 110cmStraub Medical AGDQX2022-06-30
07640142811329SET Aspirex™ S 6F 135cmStraub Medical AGDQX2022-06-30
07640142811336SET Aspirex™ S 8F 85cmStraub Medical AGDQX2022-06-30
07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
10193489078022NAMICMEDLINE INDUSTRIES, INC.DQX2022-02-24
30193489067044NAMICMEDLINE INDUSTRIES, INC.DQX2021-06-03
07613327508499Synchro SELECTStryker CorporationDQX2020-10-20
07613327508512Synchro SELECTStryker CorporationDQX2020-10-20
07613327508529Synchro SELECTStryker CorporationDQX2020-10-20
07613327508581Synchro SELECTStryker CorporationDQX2020-10-20
07613327508628Synchro SELECTStryker CorporationDQX2020-10-20
07613327508635Synchro SELECTStryker CorporationDQX2020-10-20
07640142810575SET Rotarex®S 6F 110cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810582SET Rotarex®S 6F 135cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810599SET Rotarex®S 8F 85cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810605SET Rotarex®S 8F 110 cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07613327459647Synchro2Stryker CorporationDQX2019-06-20
07613327459661Synchro2Stryker CorporationDQX2019-06-20
08498840011874VYGONVygon CorporationDQX2019-04-08
08498840011881VYGONVygon CorporationDQX2019-04-08
08498840011898VYGONVygon CorporationDQX2019-04-08
08498840011911VYGONVygon CorporationDQX2019-04-08