FDA.reportPublic FDA data

EMERALD

Primary DI
10705032055604
Brand
EMERALD
Company
Cordis US Corp.
Model
502585F
Catalog number
502585F
Device description
DGW .035 FC J3MM 175CM TEF FRM
Published
2024-02-23
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935170000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935170000CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSLake Region Mfg., Inc.1994-03-31DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032055601PackageGS15In Commercial Distribution
10705032055604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503205560120705032055601
1070503205560410705032055604

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.

Regulatory Flags#

DUNS number
118274128
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032100656VISTA BRITE TIP778-052-00M778-052-00M2024-09-09
10705032100663VISTA BRITE TIP778-082-00M778-082-00M2024-09-09
10705032100748VISTA BRITE TIP670-190-00M670-190-00M2024-09-09
10705032100830VISTA BRITE TIP670-040-00M670-040-00M2024-09-09
10705032100892VISTA BRITE TIP778-034-00M778-034-00M2024-09-09
10705032100922VISTA BRITE TIP670-008-00M670-008-00M2024-09-09
10705032100953VISTA BRITE TIP778-270-00M778-270-00M2024-09-09
10862028000434MYNX CONTROLMX6760MX67602018-10-22
10862028000427MYNX CONTROLMX5060MX50602018-10-22
20705032036440Cordis PRECISE PRO Rx Nitinol Stent SystemPC0720RXCPC0720RXC2014-09-17
10705032009768AVANTI504405X504405X2016-08-01
10705032009775AVANTI504406X504406X2016-08-01
10705032009799AVANTI504408X504408X2016-08-01
10705032009881AVANTI504509X504509X2016-08-01
10705032009898AVANTI504604A504604A2016-08-01
10705032009904AVANTI504604P504604P2016-08-01
10705032009911AVANTI504604S504604S2016-08-01
10705032009935AVANTI504604X504604X2016-08-01
10705032009942AVANTI504605A504605A2016-08-01
10705032009959AVANTI504605P504605P2016-08-01

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