Navilyst

GUDID H965970004021

Angiographic Guidewire, Fixed Core, Straight Tip

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

• Primary Device ID: H965970004021
• NIH Device Record Key: 64ac7a0a-6996-438c-bf8b-6dc9290e979e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navilyst
• Version Model Number: 97000402
• 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

Device Dimensions

• Outer Diameter: 0.038 Inch
• Length: 260 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 260 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 260 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 260 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 260 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 260 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 260 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 260 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 260 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 260 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 260 Centimeter
• Outer Diameter: 0.038 Inch
• Length: 260 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H965970004020 [Primary]
HIBCC	H965970004021 [Package]; Contains: H965970004020; Package: BOX [10 Units]; Discontinued: 2022-05-13; Not in Commercial Distribution

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: 2022-05-16
• Device Publish Date: 2016-09-19

On-Brand Devices [Navilyst]

• H965960006040: 96000604
• H965960003040: 96000304
• H965960003020: 96000302
• H965960002180: 96000218
• H749905100020: 90510002
• H749905100010: 90510001
• H965457471: Vascular Guidewire, Nitinol w/ Hydrophilic Coating, Straight, Radiopaque Tip
• H965457461: Vascular Guidewire, Nitinol w/ Hydrophilic Coating, Straight, Radiopaque Tip
• H965970005051: Angiographic Guidewire, Movable Core, J Tip
• H965970005041: Angiographic Guidewire, Movable Core, J Tip
• H965970002331: Angiographic Guidewire, Fixed Core, J Tip
• H965970002191: Angiographic Guidewire, Fixed Core, J Tip
• H965970002061: Angiographic Guidewire, Fixed Core, J Tip
• H965970002031: Angiographic Guidewire, Fixed Core, J Tip
• H965970001041: Angiographic Guidewire, Fixed Core, Straight Tip
• H965970001021: Angiographic Guidewire, Fixed Core, Straight Tip
• H965970006021: Angiographic Guidewire, Fixed Core, Straight Tip
• H965970005081: Angiographic Guidewire, Movable Core, J Tip
• H965970005071: Angiographic Guidewire, Movable Core, J Tip
• H965970005011: Angiographic Guidewire, Movable Core, J Tip
• H965970004021: Angiographic Guidewire, Fixed Core, Straight Tip
• H965970004011: Angiographic Guidewire, Fixed Core, Straight Tip
• H965970003071: Angiographic Guidewire, Fixed Core, J Tip
• H965970003021: Angiographic Guidewire, Fixed Core, J Tip
• H965970002351: Angiographic Guidewire, Fixed Core, J Tip
• H965970002321: Angiographic Guidewire, Fixed Core, J Tip
• H965970002221: Angiographic Guidewire, Fixed Core, J Tip
• H965970002161: Angiographic Guidewire, Fixed Core, J Tip
• H965970002101: Angiographic Guidewire, Fixed Core, J Tip
• H965970002081: Angiographic Guidewire, Fixed Core, J Tip
• H965970002021: Angiographic Guidewire, Fixed Core, J Tip
• H965970002011: Angiographic Guidewire, Fixed Core, J Tip
• H965970001121: Angiographic Guidewire, Fixed Core, Straight Tip
• H965970001091: Angiographic Guidewire, Fixed Core, Straight Tip
• H965970001061: Angiographic Guidewire, Fixed Core, Straight Tip
• H965970001051: Angiographic Guidewire, Fixed Core, Straight Tip
• H965970001011: Angiographic Guidewire, Fixed Core, Straight Tip
• H965960006031: Angiographic Guidewire, Fixed Core, Straight Tip
• H965960003031: Angiographic Guidewire, Fixed Core, J/Straight Tip
• H965960002171: Angiographic Guidewire, Fixed Core, J Tip