Fast Track Tunneler Set, 15" and 6"

Fast Track Tunneler Set, 15" and 6"
Fast Track - 42-3500

A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MDM

Device Name: Instrument, Manual, Surgical, General Use

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: SU

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: 878.4800

Third Party Flag: N

Medical Specialty: SU

Device Id: 50885403193529

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403193521

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 10885403193521

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