IMPLANT 1128450 CAUSSE STAPES SHEET FLPL
Causse - 1128450
Device Description
A non-sterile, flat stretch of silicone elastomer typically modified to suit the patient anatomy intended to be implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile). It may be cut into different sizes and shapes for various reconstructive or cosmetic plastic surgery applications that include repair of nasal septums, perforated eardrums, herniations, diaphragms, orbital floors, or congenital fissures of the abdominal wall.
Environmental Conditions
No Data Available
Device Sizes
- 15 MM X 8 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
Device IdentifiersDevice Id: 00681490034159
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