Perma Facial Implant

Basic Information

• Brand Name: Perma Facial Implant
• Primary DI: 00853437006011
• Version / Model: PFI 3060
• Company Name: SURGISIL, LLP
• Labeler DUNS: 010030665
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-27
• Public Version: 3
• Public Version Date: 2023-09-21
• Public Version Status: Update
• Public Device Record Key: cc54c4e6-0772-4458-a27d-e6812d587e07
• 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
59018	Lip prosthesis	A sterile device intended to be implanted in a patient to augment and/or restore the soft tissues of the upper and lower lips (lip implant). It is a cylindrical-shaped device with tapered ends that is made of solid silicone; it is available in a variety of dimensions.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853437006011	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K071823	000

Device Sizes

Type	Value	Unit	Text
Length	60	Millimeter
Outer Diameter	3	Millimeter