FDA.reportPublic FDA data

RUNTHROUGH

Primary DI
04987350744340
Brand
RUNTHROUGH
Company
TERUMO CORPORATION
Model
25-1011
Catalog number
TW*AS418XA
Device description
RUNTHROUGH NS Extra Floppy PTCA Guidewire
Published
2023-05-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
34987350744341PackageGS15In Commercial Distribution
54987350744345PackageGS15In Commercial Distribution
04987350744340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3498735074434134987350744341
5498735074434554987350744345
04987350744340049873507443404987350744340

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
Device Size Text, specify0
Length180Centimeter
Outer Diameter0.36Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedical.com

Regulatory Flags#

DUNS number
690543319
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987350700025OPTITORQUE40-5011RH*5TIG110A2016-09-09
04987350700049OPTITORQUE40-5012RH*5TIG210A2016-09-09
04987350700063OPTITORQUE40-5021RH*5BL3520A2016-09-09
04987350700087OPTITORQUE40-5022RH*5BL4020A2016-09-09
04987350700100OPTITORQUE40-5030RH*5SP0061A2016-09-09
04987350700124OPTITORQUE40-5031RH*5AP5561A2016-09-09
04987350700148OPTITORQUE40-5040RH*5SL3500A2016-09-09
04987350700162OPTITORQUE40-5041RH*5SL4000A2016-09-09
04987350700186OPTITORQUE40-5042RH*5SL5000A2016-09-09
04987350700209OPTITORQUE40-5043RH*5JR3500A2016-09-09
04987350700223OPTITORQUE40-5044RH*5JR4000A2016-09-09
04987350700247OPTITORQUE40-5045RH*5JR5000A2016-09-09
04987350700261OPTITORQUE40-5050RH*5BPIR00A2016-09-09
04987350700285OPTITORQUE40-5060RH*5SAL100A2016-09-09
04987350700308OPTITORQUE40-5061RH*5SAL200A2016-09-09
04987350700322OPTITORQUE40-6011RH*6TIG110A2016-09-09
04987350700346OPTITORQUE40-6012RH*6TIG210A2016-09-09
04987350700360OPTITORQUE40-6021RH*6BL3520A2016-09-09
04987350700384OPTITORQUE40-6022RH*6BL4020A2016-09-09
04987350700407OPTITORQUE40-6030RH*6SP0061A2016-09-09

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
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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
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