FDA.report

HI-TORQUE ADVANCE

Primary DI
08717648014482
Brand
HI-TORQUE ADVANCE
Company
ABBOTT VASCULAR INC.
Model
1044588
Catalog number
1044588
Device description
HI-TORQUE ADVANCE Guide Wire .014 Straight Tip 3.0 cm x 190 cm
Published
2016-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DQXWIRE, GUIDE, CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
28717648014486PackageGS15In Commercial Distribution
08717648014482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2871764801448628717648014486
08717648014482087176480144828717648014482

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Stored in a dry, dark, cool place

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)227-9902AV.CUSTOMERCARE@AV.ABBOTT.COM

Regulatory Flags

DUNS number
964569052
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

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08717648353765Esprit™Esprit™1212375-282025-07-12
08717648353666Esprit™Esprit™1212350-182025-07-10
08717648353680Esprit™Esprit™1212350-282025-07-10
08717648353703Esprit™Esprit™1212350-382025-07-10
08717648353741Esprit™Esprit™ 1212375-182025-07-10
08717648353789Esprit™Esprit™1212375-382025-07-10
08717648353826Esprit™Esprit™1212250-182025-07-10
08717648353840Esprit™Esprit™1212250-282025-07-10
08717648353864Esprit™Esprit™1212250-382025-07-10
08717648353987Esprit™Esprit™1212300-182025-07-10
08717648354007Esprit™Esprit™1212300-282025-07-10
08717648354021Esprit™Esprit™1212300-382025-07-10
08717648356704XACT™83024-0183024-012025-04-17
08717648356742XACT™ 83022-0183022-012025-04-17
08717648356766XACT™83020-0183020-012025-04-17
08717648356803XACT™83026-0183026-012025-04-17
08717648356810HI-TORQUE COMMAND™ 106000110600012024-11-21
08717648356827HI-TORQUE COMMAND™ 1060001A1060001A2024-11-21
08717648356834HI-TORQUE COMMAND™106000210600022024-11-21
08717648356841HI-TORQUE COMMAND™ 1060002A1060002A2024-11-21

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