- Physicians Office Resource

PREF.GUIDING SHEATH W/MULT.CRV
PREFACE - 301803M

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 use if package is damaged

Special Storage Condition, Specify

Keep Dry

Special Storage Condition, Specify

Do not use if package is opened

Special Storage Condition, Specify

Keep out of direct sunlight

Device Sizes

No Data Available

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: 10846835000047

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

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