- Physicians Office Resource

PACKING 1428010 6PK REG STRIPS POLYEST
N/A - 1428010

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

Length: 6.4 Millimeter

Width: 31.2 Millimeter

Length: 6.4 Millimeter
Width: 31.2 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 Identifiers

Device Id: 00763000039912

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: 20763000039916

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

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