Xtractor Pedal

GUDID 07290019371014

XCARDIA INNOVATION LTD

Foot-switch, electrical

• Primary Device ID: 07290019371014
• NIH Device Record Key: 996958a1-de62-4df6-bd14-28bf23a6896e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xtractor Pedal
• Version Model Number: 1
• Company DUNS: 521798660
• Company Name: XCARDIA INNOVATION LTD
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019371014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211679

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-03
• Device Publish Date: 2022-04-25

Devices Manufactured by XCARDIA INNOVATION LTD

• 07290019371014 - Xtractor Pedal: 2022-05-03
• 07290019371014 - Xtractor Pedal: 2022-05-03
• 07290019371007 - Xtractor: 2022-05-03