FDA.reportPublic FDA data

EMERALD

Primary DI
20705032055342
Brand
EMERALD
Company
CORDIS CORPORATION
Model
502548
Catalog number
502548
Device description
DGW .032 FC STR 150CM TEF
Published
2024-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20705032055342PackageGS15In Commercial Distribution
10705032055345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503205534220705032055342
1070503205534510705032055345

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806136177
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705032019057VISTA BRITE TIP598941P598941P2024-02-23
10705032019170VISTA BRITE TIP598949P598949P2024-02-23
10705032020138VISTA BRITE TIP67004800670048002024-02-23
10705032042956VISTA BRITE TIPSM7497SM74972024-02-23
10705032043069VISTA BRITE TIPSM7540SM75402024-02-23
10705032043144VISTA BRITE TIPSM7548SM75482024-02-23
10705032043151VISTA BRITE TIPSM7549SM75492024-02-23
10705032043434VISTA BRITE TIPSM7596SM75962024-02-23
10705032043779VISTA BRITE TIPSM7652SM76522024-02-23
10705032047050VISTA BRITE TIPSRA0002IGSRA0002IG2024-02-23
10705032047135VISTA BRITE TIPSRA0016IGSRA0016IG2024-02-23
10705032056625ATW Marker Wire Steerable Guidewires595MEJ014595MEJ0142021-01-26
20705032064863VISTA BRITE TIPSM7732SM77322024-02-23
20705032064870VISTA BRITE TIPSM7733SM77332024-02-23
20705032064887VISTA BRITE TIPSM7731SM77312024-02-23
20705032065143VISTA BRITE TIPSM7737SM77372024-02-23
10705032017169VISTA BRITE TIP588823E588823E2016-08-01
10705032017268VISTA BRITE TIP588830E588830E2016-08-01
10705032017299VISTA BRITE TIP588831E588831E2016-08-01
10705032017343VISTA BRITE TIP588834E588834E2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450529300SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450529713SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450529829SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450590010SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450631928InQwire® AmplatzMerit Medical Systems, Inc.DQX2026-08-21
00884450731789InQwire®Merit Medical Systems, Inc.DQX2026-08-21
00884450739709InQwire®Merit Medical Systems, Inc.DQX2026-08-21
10801902226430ARROWTELEFLEX INCORPORATEDDQX2026-08-10
10801902206241ARROWTELEFLEX INCORPORATEDDQX2026-08-03
10801902192230ARROWTELEFLEX INCORPORATEDDQX2026-08-01
04547327167215CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167222CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167239CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167246CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167253CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167260CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
10801902190908ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10801902198461ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10705032057004AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057011AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057028AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057035AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057042AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057059AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057066AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057073AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057080AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10801902193237ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193244ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902195101ARROWTELEFLEX INCORPORATEDDQX2026-07-29