Powerflex™ II Pectoral Implant ACPI2-2R

GUDID M724ACPI22R1

Contoured Carving Block Implant

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material

• Primary Device ID: M724ACPI22R1
• NIH Device Record Key: 6f48be83-0a6c-4da8-953f-c846a2d7150b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powerflex™ II Pectoral Implant
• Version Model Number: Size 2, Right
• Catalog Number: ACPI2-2R
• Company DUNS: 784664955
• Company Name: IMPLANTECH ASSOCIATES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-733-0833
• Email: info@implantech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724ACPI22R1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952708

FDA Product Code

• MIC: Implant, Muscle, Pectoralis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-14
• Device Publish Date: 2015-09-24

On-Brand Devices [Powerflex™ II Pectoral Implant]

• M724ACPI23R1: Contoured Carving Block Implant
• M724ACPI23L1: Contoured Carving Block Implant
• M724ACPI22R1: Contoured Carving Block Implant
• M724ACPI22L1: Contoured Carving Block Implant
• M724ACPI21R1: Contoured Carving Block Implant
• M724ACPI21L1: Contoured Carving Block Implant