CavaClear 500-514

GUDID 00813132022969

14F CavaClear Laser Sheath

Philips Image Guided Therapy Corporation

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• Primary Device ID: 00813132022969
• NIH Device Record Key: 96ca2043-59d5-4132-8acc-ef736f504d45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CavaClear
• Version Model Number: 500-514
• Catalog Number: 500-514
• Company DUNS: 118354223
• Company Name: Philips Image Guided Therapy 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: 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: 1-800-231-0978
• Email: complaints@spnc.com
• Phone: 1-800-231-0978
• Email: complaints@spnc.com
• Phone: 1-800-231-0978
• Email: complaints@spnc.com
• Phone: 1-800-231-0978
• Email: complaints@spnc.com
• Phone: 1-800-231-0978
• Email: complaints@spnc.com
• Phone: 1-800-231-0978
• Email: complaints@spnc.com
• Phone: 1-800-231-0978
• Email: complaints@spnc.com
• Phone: 1-800-231-0978
• Email: complaints@spnc.com
• Phone: 1-800-231-0978
• Email: complaints@spnc.com
• Phone: 1-800-231-0978
• Email: complaints@spnc.com
• Phone: 1-800-231-0978
• Email: complaints@spnc.com
• Phone: 1-800-231-0978
• Email: complaints@spnc.com
• Phone: 1-800-231-0978
• Email: complaints@spnc.com
• Phone: 1-800-231-0978
• Email: complaints@spnc.com
• Phone: 1-800-231-0978
• Email: complaints@spnc.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry; Keep away from sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813132022969 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN210024

FDA Product Code

• QRJ: Laser-Powered Inferior Vena Cava Filter Retrieval 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: 2022-03-11
• Device Publish Date: 2022-03-03

On-Brand Devices [CavaClear]

• 00813132022976: 16F CavaClear Laser Sheath
• 00813132022969: 14F CavaClear Laser Sheath