SavvyWire F3001

GUDID 07540184130016

Pre-Shaped Pressure Guidewire

Opsens 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: 07540184130016
• NIH Device Record Key: 042f331e-ed0d-4ace-8d29-595020daaf4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SavvyWire
• Version Model Number: X-Small
• Catalog Number: F3001
• Company DUNS: 253717946
• Company Name: Opsens 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: true
• 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: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com
• Phone: 1-833-677-3671
• Email: info@opsens-medical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 54 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540184030019 [Primary]
GS1	07540184130016 [Package]; Contains: 07540184030019; Package: carton box [5 Units]; In Commercial Distribution
GS1	07540184230013 [Package]; Contains: 07540184030019; Package: shipping box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213854

FDA Product Code

• DQX: Wire, Guide, Catheter

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: 2023-04-21
• Device Publish Date: 2023-04-13

On-Brand Devices [SavvyWire]

• 07540184130023: Pre-Shaped Pressure Guidewire
• 07540184130016: Pre-Shaped Pressure Guidewire