FDA.reportPublic FDA data

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II

Primary DI
28717648118757
Brand
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II
Company
ABBOTT VASCULAR INC.
Model
1009664J
Catalog number
1009664J
Device description
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire J Tip Pak 190 cm
Published
2016-03-25
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

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
28717648118757PackageGS15In Commercial Distribution
08717648118753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2871764811875728717648118757
08717648118753087176481187538717648118753

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 Diameter0.014Inch
Guidewire Length190Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, dark, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717648175060StarClose SE™ 14679-0514679-052014-11-21
08717648000621Prostar™ 12322-0112322-012014-11-21
08717648199059XIENCE ALPINE1125225-081125225-082014-11-21
08717648199066XIENCE ALPINE1125225-121125225-122014-11-21
08717648199073XIENCE ALPINE1125225-151125225-152014-11-21
08717648199080XIENCE ALPINE1125225-181125225-182014-11-21
08717648199097XIENCE ALPINE1125225-231125225-232014-11-21
08717648199103XIENCE ALPINE1125225-281125225-282014-11-21
08717648199141XIENCE ALPINE1125250-081125250-082014-11-21
08717648199158XIENCE ALPINE1125250-121125250-122014-11-21
08717648199165XIENCE ALPINE1125250-151125250-152014-11-21
08717648199172XIENCE ALPINE1125250-181125250-182014-11-21
08717648199189XIENCE ALPINE1125250-231125250-232014-11-21
08717648199196XIENCE ALPINE1125250-281125250-282014-11-21
08717648199202XIENCE ALPINE1125250-331125250-332014-11-21
08717648199219XIENCE ALPINE1125250-381125250-382014-11-21
08717648199233XIENCE ALPINE1125275-081125275-082014-11-21
08717648199240XIENCE ALPINE1125275-121125275-122014-11-21
08717648199257XIENCE ALPINE1125275-151125275-152014-11-21
08717648199264XIENCE ALPINE1125275-181125275-182014-11-21

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Primary DI, Brand, Company table
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