FDA.reportPublic FDA data

Cypress 14 Guidewire

Primary DI
00850076777432
Brand
Cypress 14 Guidewire
Company
Arbor Endovascular LLC
Model
UCYP14SO315S09
Device description
"0.014"" Cypress Guidewire, Soft, Straight Tip, 315cm, 10cm"
Published
2026-03-11
Public version status
New
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
MOFGuide, Wire, Catheter, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
MOFGuide, Wire, Catheter, NeurovasculatureCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850076777432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850076777432008500767774328500767774320850076777432

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
134667282
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850076777326Willow 18 GuidewireUWIL18SO215S2026-03-16
00850076777333Willow 18 GuidewireUWIL18ST215S2026-03-16
00850076777401Cypress 14 GuidewireUCYP14SO200S092026-03-11
00850076777418Cypress 14 GuidewireUCYP14ST200S092026-03-11
00850076777425Cypress 14 GuidewireUCYP14SU200S092026-03-11
00850076777449Cypress 14 GuidewireUCYP14ST315S092026-03-11
00850076777456Cypress 14 GuidewireUCYP14SU315S092026-03-11
00850076777463Cypress 14 GuidewireUCYP14SO200L092026-03-11
00850076777470Cypress 14 GuidewireUCYP14ST200L092026-03-11
00850076777487Cypress 14 GuidewireUCYP14SU200L092026-03-11
00850076777203Willow 14 GuidewireUSTA14SO215S092025-12-05
00850076777210Willow 14 GuidewireUSTA14ST215S092025-12-05
00850076777227Willow 14 GuidewireUSTA14SU215S092025-12-05
00850076777234Willow 14 GuidewireUSTA14SO315S092025-12-05
00850076777241Willow 14 GuidewireUSTA14ST315S092025-12-05
00850076777258Willow 14 GuidewireUSTA14SU315S092025-12-05
00850076777265Willow 14 GuidewireUSTA14SO215L092025-12-05
00850076777272Willow 14 GuidewireUSTA14ST215L092025-12-05
00850076777289Willow 14 GuidewireUSTA14SU215L092025-12-05
00850076777296Willow 14 GuidewireUSTA14SO315L092025-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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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
07613327459630Synchro2Stryker CorporationMOF2019-06-20
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07613327459654Synchro2Stryker CorporationMOF2019-06-20