FDA.reportPublic FDA data

ASAHI Gaia Third

Primary DI
04547327094795
Brand
ASAHI Gaia Third
Company
ASAHI INTECC CO., LTD.
Model
AHW14R311P
Published
2016-09-16
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
14547327094792PackageGS15In Commercial Distribution
04547327094795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454732709479214547327094792
04547327094795045473270947954547327094795

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
Length300Centimeter
Outer Diameter0.014Inch

Regulatory Flags#

DUNS number
690711189
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547327159517CHIKAI Nexus petitAIN-CNX-006-2202026-03-18
04547327159524CHIKAI Nexus petitAIN-CNX-006-220RC2026-03-18
04547327159531CHIKAI Nexus petitAIN-CNX-006-220J2026-03-18
04547327165563ASAHI VelouteVEL105-16SNK2026-02-05
04547327165570ASAHI VelouteVEL125-16SNK2026-02-05
04547327165587ASAHI VelouteVEL150-16SNK2026-02-05
04547327165594ASAHI Veloute C3VEL105-16SNC3K2026-02-05
04547327165600ASAHI Veloute C3VEL125-16SNC3K2026-02-05
04547327165617ASAHI Veloute C3VEL150-16SNC3K2026-02-05
04547327165624ASAHI TellusTLS105-16SNK2026-02-05
04547327165631ASAHI TellusTLS125-16SNK2026-02-05
04547327165648ASAHI TellusTLS150-16SNK2026-02-05
04547327165655ASAHI Tellus C3TLS105-16SNC3K2026-02-05
04547327165662ASAHI Tellus C3TLS125-16SNC3K2026-02-05
04547327165679ASAHI Tellus C3TLS150-16SNC3K2026-02-05
04547327163361CROSSLEAD Pro 018CPR01810S2025-12-15
04547327163378CROSSLEAD Pro 018CPR01810P2025-12-15
04547327163385CROSSLEAD Pro 018CPR01820S2025-12-15
04547327163392CROSSLEAD Pro 018CPR01820P2025-12-15
04547327163408CROSSLEAD Pro 018CPR01823S2025-12-15

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