FDA.reportPublic FDA data

"ENROUTE .014"" Guidewire"

Primary DI
00811311020546
Brand
"ENROUTE .014"" Guidewire"
Company
Silk Road Medical, Inc.
Model
11686-01
Catalog number
SR-014-GW
Device description
"ENROUTE .014"" Guidewire, US"
Published
2017-03-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00811311020546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811311020546008113110205468113110205460811311020546

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin, sterile wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-410-8227customerservice@silkroadmed.com

Regulatory Flags#

DUNS number
022516829
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811311021260ENROUTE Transcarotid StentFG11815SR-080630-TCS2023-06-22
00811311021277ENROUTE Transcarotid StentFG11815SR-080640-TCS2023-06-22
00811311021284ENROUTE Transcarotid StentFG11815SR-090730-TCS2023-06-22
00811311021291ENROUTE Transcarotid StentFG11815SR-090740-TCS2023-06-22
00811311021307ENROUTE Transcarotid StentFG11815SR-100830-TCS2023-06-22
00811311021314ENROUTE Transcarotid StentFG11815SR-100840-TCS2023-06-22
00811311021321ENROUTE Transcarotid StentFG11815SR-100740-TCS2023-06-22
00811311020362ENROUTE Transcarotid StentSR-0520-CSSR-0520-CS2016-07-28
00811311020379ENROUTE Transcarotid StentSR-0530-CSSR-0530-CS2016-07-28
00811311020386ENROUTE Transcarotid StentSR-0540-CSSR-0540-CS2016-07-28
00811311020393ENROUTE Transcarotid StentSR-0620-CSSR-0620-CS2016-07-28
00811311020409ENROUTE Transcarotid StentSR-0630-CSSR-0630-CS2016-07-28
00811311020416ENROUTE Transcarotid StentSR-0640-CSSR-0640-CS2016-07-28
00811311020423ENROUTE Transcarotid StentSR-0720-CSSR-0720-CS2016-07-28
00811311020430ENROUTE Transcarotid StentSR-0730-CSSR-0730-CS2016-07-28
00811311020447ENROUTE Transcarotid StentSR-0740-CSSR-0740-CS2016-07-28
00811311020454ENROUTE Transcarotid StentSR-0820-CSSR-0820-CS2016-07-28
00811311020461ENROUTE Transcarotid StentSR-0830-CSSR-0830-CS2016-07-28
00811311020478ENROUTE Transcarotid StentSR-0840-CSSR-0840-CS2016-07-28
00811311020485ENROUTE Transcarotid StentSR-0920-CSSR-0920-CS2016-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818075011261AristotleSCIENTIA VASCULAR LLCDQX2026-09-21
10801902226614ARROWTELEFLEX INCORPORATEDDQX2026-08-28
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