UroWire® Guidewire with SL-6® Hydrophilic Coating Urological Guidewire

GUDID 10607915113831

APPLIED MEDICAL RESOURCES CORPORATION

General-purpose non-vascular guidewire General-purpose non-vascular guidewire General-purpose non-vascular guidewire

• Primary Device ID: 10607915113831
• NIH Device Record Key: d99a4c63-729e-4adf-8be8-1fc184642399
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UroWire® Guidewire with SL-6® Hydrophilic Coating
• Version Model Number: B8134
• Catalog Number: Urological Guidewire
• Company DUNS: 187129135
• Company Name: APPLIED MEDICAL RESOURCES CORPORATION
• 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: 1.949.713.8300
• Email: contact@appliedmedical.com
• Phone: 1.949.713.8300
• Email: contact@appliedmedical.com
• Phone: 1.949.713.8300
• Email: contact@appliedmedical.com

Device Dimensions

• Outer Diameter: 0.35 Inch
• Outer Diameter: 0.35 Inch
• Outer Diameter: 0.35 Inch
• Outer Diameter: 0.35 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.35 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607915113834 [Primary]
GS1	10607915113831 [Package]; Contains: 00607915113834; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• KNY: Accessories, Catheter, G-U

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-18

On-Brand Devices [UroWire® Guidewire with SL-6® Hydrophilic Coating]

• 10607915113855: Urological Guidewire
• 10607915113831: B8134