Xtractor

GUDID 07290019371007

XCARDIA INNOVATION LTD

Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use Vascular dilator, single-use

• Primary Device ID: 07290019371007
• NIH Device Record Key: f3f02b89-25a6-4831-98ed-afbc6d0b49a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xtractor
• Version Model Number: 1
• Company DUNS: 521798660
• Company Name: XCARDIA INNOVATION LTD
• Device Count: 3
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019371007 [Unit of Use]
GS1	37290019371008 [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: true

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