AccessGUDID - DEVICE: Powerflex™ Pectoral Implant, Aiache Style 1, SDM (M724ACPI1T2L1)

GUDID

Device Identifier (DI) Information

Brand Name: Powerflex™ Pectoral Implant, Aiache Style 1, SDM
Version or Model: Size: 2, Left Side
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ACPI1-T-2L
Company Name: IMPLANTECH ASSOCIATES, INC.

Primary DI Number: M724ACPI1T2L1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784664955 *Terms of Use

Device Description: Pectoral Implant

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MIC	Implant, Muscle, Pectoralis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K944163	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f1dfc8d3-06f2-4211-abb4-23e6ace72521
Public Version Date: March 31, 2025
Public Version Number: 6
DI Record Publish Date: August 08, 2017