SHUNT 1156404 AUSTIN ENDOLYMPHATIC
Austin - 1156404
Device Description
A sterile tube or sheet surgically implanted in the membranous labyrinth of the inner ear to drain excess endolymphatic fluid typically as treatment for Meniere's disease, an inner ear disorder. The device permits unrestricted flow of the fluid from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. It is typically made of silicone. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Chamber Diameter is 2.0 MM
- Chamber Length is 3.5 MM
- Length: 18.0 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: ESZ
Device Name: Tube, Shunt, Endolymphatic
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: 874.3820
Third Party Flag: N
Medical Specialty: EN
Device IdentifiersDevice Id: 00681490035798
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