- Physicians Office Resource

PINNACLE PRECISION ACCESS SYSTEM Introducer Sheath
PINNACLE PRECISION ACCESS SYSTEM - 70-4165

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

Special Storage Condition, Specify

Do not store at extreme temperature and humidity

Special Storage Condition, Specify

Avoid direct sunlight

Device Sizes

Length: 10 Centimeter

Contents: Stiff Sheath, Dilator, Guidewire (0.021 Inch Nitinol) and Needle (21 Gauge Taper Tip Echogenic)

Catheter Gauge: 4 French

Length: 10 Centimeter
Contents: Stiff Sheath, Dilator, Guidewire (0.021 Inch Nitinol) and Needle (21 Gauge Taper Tip Echogenic)
Catheter Gauge: 4 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 Identifiers

Device Id: 30389701010862

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00389701010861

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Shelfbox

Device Id: 00389701010861

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: 50389701010866

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 30389701010862

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

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