PROSTHESIS 1156278 DE LA CRUZ .6X3.75

PROSTHESIS 1156278 DE LA CRUZ .6X3.75
Del La Cruz - 1156278

Device Description

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.

Environmental Conditions

No Data Available

Device Sizes

Length: 3.75 Millimeter

Shaft Diameter is 0.6 MM

Shaft Length is 1.25 MM

Length: 3.75 Millimeter
Shaft Diameter is 0.6 MM
Shaft Length is 1.25 MM

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 00681490035347

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