FDA.reportPublic FDA data

Aristotle

Primary DI
00818075010264
Brand
Aristotle
Company
SCIENTIA VASCULAR LLC
Model
14-300-004
Catalog number
Z14-300-004
Device description
Guidewire 300cm Extra Support
Published
2023-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
00818075010264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818075010264008180750102648180750102640818075010264

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Guidewire Diameter0
Guidewire Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
888.385.9016regulatory@scientiavascular.com

Regulatory Flags#

DUNS number
011234178
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818075010233Aristotle14-200-003Z14-200-0032023-09-25
00818075010240Aristotle14-200-004Z14-200-0042023-09-25
00818075010257Aristotle14-300-003Z14-300-0032023-09-25
00818075010004Aristotle14-200-001A14-200-0012020-02-24
00818075010011Aristotle14-200-002A14-200-0022020-02-24
00818075010028Aristotle14-300-001A14-300-0012020-02-24
00818075010035Aristotle14-300-002A14-300-0022020-02-24
00818075011261Aristotle01672AMN-225-0022026-09-21
00818075011209SocratesSC038-156-0012025-05-27
00818075011216SocratesSC038-127-0012025-05-27
00818075010080Plato27BPL273-150-0012016-08-24
00818075011179Aristotle01862A18-200-0012025-08-01
00818075011186Aristotle01863A18-200-0022025-08-01
00818075011193Aristotle01864A18-200-0032025-08-01
00818075010059Volo14-200-002V14-200-0022020-03-03
00818075010042Volo14-200-001V14-200-0012020-02-24
00818075010066Volo14-300-001V14-300-0012020-02-24
00818075010073Volo14-300-002V14-300-0022020-02-24
00818075010776SocratesSC038-156-0012023-11-14
00818075010790SocratesTS-254-1102023-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30801902124921ARROWTELEFLEX INCORPORATEDDQX2026-10-13
07540184010127OptoMonitorOpsens IncDQX2026-09-30
07540184020027OptoMonitorOpsens IncDQX2026-09-30
07540184020034OptoMOnitorOpsens IncDQX2026-09-30
07540184020041OptoMonitorOpsens IncDQX2026-09-30
07540184020058OptoMonitorOpsens IncDQX2026-09-30
07540184020065OptoMonitorOpsens IncDQX2026-09-30
07540184020072OptoMonitorOpsens IncDQX2026-09-30
00818075011261AristotleSCIENTIA VASCULAR LLCDQX2026-09-21
00818075011261AristotleSCIENTIA VASCULAR LLCMOF2026-09-21
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
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQX2026-02-24
00818075010233AristotleSCIENTIA VASCULAR LLCMOF2023-09-25
00818075010233AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010240AristotleSCIENTIA VASCULAR LLCMOF2023-09-25
00818075010240AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
00818075010257AristotleSCIENTIA VASCULAR LLCMOF2023-09-25
00818075010257AristotleSCIENTIA VASCULAR LLCDQX2023-09-25
10801902202984ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902203073ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210583ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210590ARROWTELEFLEX INCORPORATEDDQX2023-06-06
10801902210613ARROWTELEFLEX INCORPORATEDDQX2023-06-06