Standalone StruXure Guidewire A032600

GUDID 10801741099349

Standalone .032 inch Guidewire

Bard Access Systems, Inc.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID10801741099349
NIH Device Record Keyc0d39ab4-3374-4638-80d7-572bd7f03983
Commercial Distribution StatusIn Commercial Distribution
Brand NameStandalone StruXure Guidewire
Version Model NumberA032600
Catalog NumberA032600
Company DUNS044611812
Company NameBard Access Systems, 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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)545-0890
Emailmedical.services@crbard.com
Phone+1(800)545-0890
Emailmedical.services@crbard.com

Device Dimensions

Outer Diameter0.032 Inch
Outer Diameter0.032 Inch
Outer Diameter0.032 Inch
Outer Diameter0.032 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741099342 [Primary]
GS110801741099349 [Package]
Contains: 00801741099342
Package: CA [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWIRE, GUIDE, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

On-Brand Devices [Standalone StruXure Guidewire]

10801741099356Standalone .035 inch Guidewire
10801741099349Standalone .032 inch Guidewire

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