- Physicians Office Resource

VENT TUBE 14311 5PK MINI SHAH .76MM FLPL
Shah - 14311

Device Description

A small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: ETD

Device Name: Tube, Tympanostomy

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: EN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 874.3880

Third Party Flag: N

Medical Specialty: EN

Device Identifiers

Device Id: 20763000282992

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00763000282998

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PK

Device Id: 00763000282998

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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