FDA.reportPublic FDA data

TORAYGUIDE GUIDEWIRE

Primary DI
04960685200798
Brand
TORAYGUIDE GUIDEWIRE
Company
TORAY INDUSTRIES,INC.
Model
TRG-25230
Published
2016-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
14960685200795PackageGS11In Commercial Distribution
04960685200798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1496068520079514960685200795
04960685200798049606852007984960685200798

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length230Centimeter
Outer Diameter0.64Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at controlled room temperature.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2815872299xx@xx.xx
2815872299orders_med.tiam.mb@mail.toray

Regulatory Flags#

DUNS number
690535422
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14960685201228INOUE BALLOON APTAV-20R2023-06-01
14960685201235INOUE BALLOON APTAV-22R2023-06-01
14960685201242INOUE BALLOON APTAV-24R2023-06-01
14960685201259INOUE BALLOON APTAV-26R2023-06-01
14960685201341INOUE BALLOON APTAV-16R2023-06-01
14960685201358INOUE BALLOON APTAV-18R2023-06-01
14960685201389INOUE BALLOON APTAV-16RP2023-06-01
14960685201396INOUE BALLOON APTAV-18RP2023-06-01
14960685201402INOUE BALLOON APTAV-20RP2023-06-01
14960685201419INOUE BALLOON APTAV-22RP2023-06-01
14960685201426INOUE BALLOON APTAV-24RP2023-06-01
14960685201433INOUE BALLOON APTAV-26RP2023-06-01
04960685205021PRESSANAOPC-03081352017-03-22
04960685205038PRESSANAOPC-03151352017-03-22
04960685205427PRESSANAOPC-07081352017-03-22
04960685200781TORAYGUIDE GUIDEWIRETRG-251752016-07-22
14960685200030Inoue Balloon CatheterPTMC-262014-09-17
14960685200047Inoue Balloon CatheterPTMC-282014-09-17
14960685200054Inoue Balloon CatheterPTMC-302014-09-17
14960685205028PRESSANAOPC-03081352017-03-22

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