Standalone StruXure Guidewire A035700

GUDID 10801741099356

Standalone .035 inch Guidewire

Bard Access Systems, Inc.

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 10801741099356
• NIH Device Record Key: 15abd5ed-8648-4d12-95f2-3b149d801d10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standalone StruXure Guidewire
• Version Model Number: A035700
• Catalog Number: A035700
• Company DUNS: 044611812
• Company Name: Bard Access Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com

Device Dimensions

• Outer Diameter: 0.035 Inch
• Outer Diameter: 0.035 Inch
• Outer Diameter: 0.035 Inch
• Outer Diameter: 0.035 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741099359 [Primary]
GS1	10801741099356 [Package]; Contains: 00801741099359; Package: CA [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143135

FDA Product Code

• DQX: WIRE, GUIDE, CATHETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [Standalone StruXure Guidewire]

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