SHEET 1532500 10PK SILICONE 5X5CM .25MM
N/A - 1532500
Device Description
A flat stretch of silicone elastomer typically modified to suit the patient anatomy and intended to be implanted for tissue reconstruction during a surgical procedure. The device may be reinforced (e.g., with polyester textile), and may be cut into different sizes and shapes for various reconstructive surgery applications (e.g., repair of nasal septum or orbital floor, perforated eardrum, or hernia/fissure of abdominal wall).
Environmental Conditions
No Data Available
Device Sizes
- Width: 0.25 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KHJ
Device Name: Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
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: 874.3620
Third Party Flag: N
Medical Specialty: EN
Device IdentifiersDevice Id: 20763000040219
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00763000040215
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PK
Device Id: 00763000040215
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