Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs

Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs
Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs - 0884-00-0019-21

A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

No Data Available

• Catheter Gauge: 7.5 French

Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

• Ethylene Oxide

Code: DSP

Device Name: System, Balloon, Intra-Aortic And Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.3535

Third Party Flag: N

Medical Specialty: CV

Device Id: 10607567108025

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A