LEAD INTRODUCER KIT SPLIT 6212
NA - 6212-S5
Device Description
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.
Environmental Conditions
- 40.00
- N/A
Device Sizes
- Introducer inner diameter 12 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DYB
Device Name: Introducer, Catheter
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: 870.1340
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 20643169646326
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00643169646322
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PK
Device Id: 00643169646322
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