- Physicians Office Resource

Laryngectomy Tube
Shiley - 6LGT

Device Description

A hollow device intended to maintain tracheostoma patency immediately after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis (narrowing) in the months following the procedure. It is a soft plastic or silicone curved/contoured tube, similar to a tracheostomy tube, and may have an inner cannula and be fenestrated to allow simultaneous use with a tracheoesophageal speech valve. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. This is a reusable device.

Environmental Conditions

Handling Environment Temperature - Degrees Fahrenheit

120.00
N/A

Device Sizes

Length: 50 Millimeter

Inner Diameter, 6.4, mm; Outer Diameter, 11.1, mm;

Length: 50 Millimeter
Inner Diameter, 6.4, mm; Outer Diameter, 11.1, mm;

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: JOH

Device Name: Tube Tracheostomy And Tube Cuff

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 868.5800

Third Party Flag: Y

Medical Specialty: AN

Device Identifiers

Device Id: 60884522007097

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 50884522007090

Package Quantity: 108

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 50884522007090

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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