PINNACLE Introducer Sheath
PINNACLE - RSS505
Device Description
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.
Environmental Conditions
- Avoid direct sunlight.
- Do not store at extreme temperature and humidity.
Device Sizes
- Catheter Gauge: 5 French
- Length: 25 Centimeter
- Guidewire Compatibility: 0.038 Inch
- Contents: Sheath and Dilator
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: 30389701007398
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00389701007397
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Shelfbox
Device Id: 00389701007397
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
Device Id: 50389701007392
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 30389701007398
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Carton