SU-POR Surgical Implant

Basic Information

• Brand Name: SU-POR Surgical Implant
• Primary DI: 00815285024005
• Version / Model: 4622
• Catalog Number: 4622
• Company Name: PORIFEROUS, LLC
• Labeler DUNS: 078388975
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-01
• Public Version: 1
• Public Version Date: 2022-08-09
• Public Version Status: New
• Public Device Record Key: 3efb38a7-a6db-4c65-9b69-db88c64cca96

Device Description

Su-Por Ear 4622 - Left - 34mm x 46mm x 28mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KKY	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction	General, Plastic Surgery	878.3500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33310	Polyethylene craniofacial tissue reconstructive material	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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815285024005	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140437	000