PROSTHESIS 0564 MILLEN FLEX H/A OFF TOT

PROSTHESIS 0564 MILLEN FLEX H/A OFF TOT
Millen - 0564

A sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and 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 polymers.

No Data Available

• Shaft Diameter is 1.0 MM
• Head Diameter is 4.0 MM
• Length: 9.0 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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

Device Id: 00681490024785

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