AART Pectoralis Implant

Basic Information

• Brand Name: AART Pectoralis Implant
• Primary DI: B4905001035C0
• Version / Model: C
• Catalog Number: 500-103-5C
• Company Name: Aart
• Labeler DUNS: 091356894
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-20
• Public Version: 6
• Public Version Date: 2025-08-22
• Public Version Status: Update
• Public Device Record Key: 16b4f2be-11ee-4a6a-a695-e091b5b575c6
• Distribution End Date: 2022-07-22

Device Description

Pectoral Sty 1 Sz 3 L Sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Sterilization Methods: Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MIC	Implant, muscle, pectoralis	Ear, Nose, Throat	874.3620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48163	Pectoral implant	An implantable device designed for cosmetic augmentation (submuscular implantation) or reconstruction (e.g., to correct injuries/congenital absence) of the pectoral muscle(s). It is a preshaped (e.g., convex/concave oval-shaped) device typically composed of silicone elastomer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B4905001035C0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K021337	000