HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL 1009663J

GUDID 08717648065897

BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 J Tip w/o markers 3.0 cm x 300 cm

ABBOTT VASCULAR INC.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID08717648065897
NIH Device Record Key57b062e8-df12-4691-8a6a-9b40ab7668b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameHI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
Version Model Number1009663J
Catalog Number1009663J
Company DUNS964569052
Company NameABBOTT VASCULAR INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry, dark, cool place.

Device Identifiers

Device Issuing AgencyDevice ID
GS108717648065897 [Primary]
GS128717648065891 [Package]
Package: Case [5 Units]
In Commercial Distribution

FDA Product Code

DQXWIRE, GUIDE, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-03-25
Device Publish Date2016-03-25

On-Brand Devices [HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL]

08717648065897BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 J Tip w/o markers 3.0 cm x 300 cm
28717648065884BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 J Tip w/o markers 3.0 cm x 190 cm
28717648065877HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 J Tip 3.0 cm x 300 cm
08717648014369HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 Straight Tip w/o marker 300 cm
28717648014356HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 StraightTip w/o marker 190 cm
28717648014349HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 Straight Tip 3.0 cm x 300 cm
28717648014332HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 Straight Tip 3.0 cm x 190 cm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.