PROSTHESIS 1156621 PLAT/TI .5X4.5MM RT
Big Easy® Piston - 1156621
Device Description
A sterile device intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of metal [e.g., stainless steel, titanium (Ti)], polymers, or a combination of these materials.
Environmental Conditions
No Data Available
Device Sizes
- Length: 4.5 Millimeter
- Offset = 1.5 mm
- Shaft Diameter = 0.5 mm
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: ETA
Device Name: Replacement, Ossicular Prosthesis, Total
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: 874.3495
Third Party Flag: N
Medical Specialty: EN
Code: ETB
Device Name: Prosthesis, Partial Ossicular Replacement
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: 874.3450
Third Party Flag: N
Medical Specialty: EN
Device IdentifiersDevice Id: 00763000036621
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