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PowerFlex™ Pectoral Implant Sizer

FDA UDI

Class II (US FDA UDI)

by Implantech Associates, Inc.

Identity

Trade Name
PowerFlex™ Pectoral Implant Sizer FDA UDI
Generic Name
Pectoral implant FDA UDI
Device Name
Pectoral Implant Sizer FDA UDI
Model / Reference
Aiache Style 4 / Size 2/ Left FDA UDI
Description
Pectoral Implant Sizer FDA UDI

Identifiers

Catalog Number
ACPI4-2L-SIZ-NS FDA UDI
Primary DI / UDI-DI
M724ACPI42LSIZNS1 FDA UDI
510(k) Number
K944163 FDA UDI
FDA Product Code
MIC FDA UDI
GMDN Term
Pectoral implant FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3620 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Pectoral implant

PowerFlex™ Pectoral Implant Sizer by Implantech Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pectoral implant.

Cleared under the same submission

K944163 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Implantech Associates, Inc.

Sources (1)

  • FDA UDI af0fbeb4-1483-4402-9c2e-2207ad08c081 36 fields · synced Jun 9, 2026