Perma Facial Implant

Basic Information

• Brand Name: Perma Facial Implant
• Primary DI: 00853437006059
• Version / Model: PFI 4065
• Company Name: SURGISIL, LLP
• Labeler DUNS: 010030665
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-19
• Public Version: 4
• Public Version Date: 2023-09-21
• Public Version Status: Update
• Public Device Record Key: be4c8a45-9a46-4b61-b2db-c20b5137ed3d
• Distribution End Date: 2023-04-05

Device Description

silicone soft tissue facial implant..

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
ODU	Facial Implant	General, Plastic Surgery	878.3500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45228	Malar prosthesis	An implantable device designed to augment or maintain the soft-tissue anatomy of the malar area (cheek). The device is typically a solid elastomer (e.g., silicone) available in several shapes and sizes for subdermal implantation in the malar area for cosmetic or reconstructive purposes following traumatic or disease/congenital deformation. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853437006059	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K071823	000

Device Sizes

Type	Value	Unit	Text
Length	65	Millimeter
Outer Diameter	4	Millimeter