PACKING 1428005 6PK LONG STRIPS POLYEST
N/A - 1428005
Device Description
A sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Width: 50.8 Millimeter
- Length: 6.4 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NOK
Device Name: Material, External Aesthetic Restoration, No Adhesive
Device Class: 1
Physical State: N/A
Definition: external aesthetic restoration prosthesis
Submission Type ID: 4
Review Panel: SU
Review Code: N/A
Technical Method: Y
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 878.3800
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 00763000039905
Device Type: Unit of Use
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
Device Id: 20763000039909
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