transGlide Expandable Introducer TA-004

GUDID 00866697000200

16F transGlide Expandable Introducer

TRANS AORTIC MEDICAL INC

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 00866697000200
• NIH Device Record Key: 9b81a326-07ec-4282-9588-e6abc8d4b8aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: transGlide Expandable Introducer
• Version Model Number: 16F transGlide Expandable Introducer
• Catalog Number: TA-004
• Company DUNS: 071067163
• Company Name: TRANS AORTIC MEDICAL INC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com
• Phone: 4087794200
• Email: mcarley@transaortic.com

Device Dimensions

• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter
• Lumen/Inner Diameter: 5.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866697000200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152194

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-09-01

On-Brand Devices [transGlide Expandable Introducer]

• 00866697000224: 20F transGlide Expandable Introducer
• 00866697000217: 18F transGlide Expandable Introducer
• 00866697000200: 16F transGlide Expandable Introducer