STEERABLE GUIDE CATHETER SGC0301

GUDID 08717648216824

Steerable Guide Catheter

ABBOTT VASCULAR INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use
Primary Device ID08717648216824
NIH Device Record Keyce660628-1f76-4aba-8fec-dfc2ae040966
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTEERABLE GUIDE CATHETER
Version Model NumberSGC0301
Catalog NumberSGC0301
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
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 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS108717648216824 [Primary]

FDA Product Code

DRACATHETER, STEERABLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-07-23
Device Publish Date2016-09-22

Devices Manufactured by ABBOTT VASCULAR INC.

28717648013427 - HI-TORQUE BALANCE2024-03-25 HI-TORQUE BALANCE Guide Wire .014 Straight Tip 3.0 cm x 190 cm
28717648013434 - HI-TORQUE BALANCE2024-03-25 HI-TORQUE BALANCE Guide Wire .014 Straight Tip 3.0 cm x 300 cm
28717648014332 - HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL2024-03-25 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 Straight Tip 3.0 cm x 190 cm
28717648014349 - HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL2024-03-25 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 Straight Tip 3.0 cm x 300 cm
28717648014356 - HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL2024-03-25 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 StraightTip w/o marker 190 cm
08717648014369 - HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL2024-03-25 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire .014 Straight Tip w/o marker 300 cm
08717648015489 - HI-TORQUE BALANCE HEAVYWEIGHT2024-03-25 HI-TORQUE BALANCE HEAVYWEIGHT Guide Wire w/Hydrocoat .014 Straight 4.5 cm x 190 cm
08717648015496 - HI-TORQUE BALANCE HEAVYWEIGHT2024-03-25 HI-TORQUE BALANCE HEAVYWEIGHT Guide Wire w/Hydrocoat .014 J Tip 4.5 cm x 190 cm

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