- Physicians Office Resource

VALVULOTOME (DETACHABLE TYPE)
VALVULOTOME (DETACHABLE TYPE) - C-0104B

Device Description

A hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). This is a reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

Moist Heat or Steam Sterilization

Moist Heat or Steam Sterilization

Product Codes

Code: DWX

Device Name: Stripper, Artery, Intraluminal

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: 870.4875

Third Party Flag: Y

Medical Specialty: CV

Device Identifiers

Device Id: 14953170047692

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170047695

Package Quantity: 1

Package Discontinue Date: 8/15/2022 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A

Device Id: 04953170047695

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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