Ikon 18 Pro Guidewire ICGW018200P

GUDID 00812212030856

Imperative Care Neurovascular Guidewire-Support, 0.018", 200cm

IMPERATIVE CARE, INC.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00812212030856
• NIH Device Record Key: 4773ac2c-dbba-431d-a430-2dd2f9827c34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ikon 18 Pro Guidewire
• Version Model Number: ICGW018200P
• Catalog Number: ICGW018200P
• Company DUNS: 080816678
• Company Name: IMPERATIVE CARE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com
• Phone: 1-408-502-7548
• Email: CustomerService@Imperativecare.com

Device Dimensions

• Outer Diameter: 0.014 Inch
• Guidewire Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Guidewire Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Guidewire Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Guidewire Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Guidewire Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Guidewire Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Guidewire Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Guidewire Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Guidewire Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Guidewire Length: 300 Centimeter
• Outer Diameter: 0.014 Inch
• Guidewire Length: 300 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812212030856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K244061

FDA Product Code

• MOF: Guide, Wire, Catheter, Neurovasculature

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-02
• Device Publish Date: 2025-11-24

On-Brand Devices [Ikon 18 Pro Guidewire]

• 00812212030863: Imperative Care Neurovascular Guidewire-Support, 0.018", 260cm
• 00812212030856: Imperative Care Neurovascular Guidewire-Support, 0.018", 200cm