FDA.reportPublic FDA data

"ENROUTE .014"" Guidewire"

Primary DI
10811311020543
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
10811311020543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081131102054310811311020543

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin 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

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Primary DI, Brand, Company table
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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
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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
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