Pectoralis Implant

Basic Information

• Brand Name: Pectoralis Implant
• Primary DI: B049ACP31RS0
• Version / Model: ACP 3-1 R S
• Catalog Number: ACP 3-1 R S
• Company Name: Hanson Medical, Inc.
• Labeler DUNS: 058759296
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-14
• Public Version: 5
• Public Version Date: 2023-07-18
• Public Version Status: Update
• Public Device Record Key: 84595c05-a35c-4224-9f73-109fe1c10994

Device Description

Non-sterile, silicone, pectoralis implant, right, sizer.

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam 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
48162	Pectoral implant, non-sterile	A non-sterile 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. It is intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B049ACP31RS0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K973729	000