Navylist

GUDID H965481080

GUIDEWIRE, 0.018 X 65CM Ni/Tu

NAVILYST MEDICAL, INC.

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

• Primary Device ID: H965481080
• NIH Device Record Key: cc40e5db-d92a-4f7d-97e9-f0e30f614f99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navylist
• Version Model Number: 48-108
• Company DUNS: 809699023
• Company Name: NAVILYST MEDICAL, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com

Device Dimensions

• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684023795 [Secondary]
HIBCC	H965481080 [Primary]
HIBCC	H965481081 [Package]; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170775

FDA Product Code

• GAA: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-03
• Device Publish Date: 2017-08-07

On-Brand Devices [Navylist]

• H965481080: GUIDEWIRE, 0.018 X 65CM Ni/Tu
• H965481070: GUIDEWIRE, 1.5MM J-.035-80-R0SEN-PTFE
• H965481060: GUIDEWIRE, 1.5MM J-.038-150-ROSEN-PTFE
• H965481050: GUIDEWIRE, 1.5MM J-.038-80-ROSEN-PTFE