Transvalvular Insertion Tool (TVI) 667612-100

GUDID 00885672010058

Transvalvular Insertion Tool, 11F

Oscor Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00885672010058
• NIH Device Record Key: e6f311fc-e445-4d45-b7ed-e189cb1c00c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transvalvular Insertion Tool (TVI)
• Version Model Number: 667612-100
• Catalog Number: 667612-100
• Company DUNS: 101835833
• Company Name: Oscor Inc.
• Device Count: 25
• 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(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com

Device Dimensions

• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter
• Length: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885672010058 [Unit of Use]
GS1	30885672010059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122084

FDA Product Code

• DYB: INTRODUCER, 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: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [Transvalvular Insertion Tool (TVI)]

• 20802526552704: Transvalvular Insertion Tool, 11F
• 00885672010058: Transvalvular Insertion Tool, 11F