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Pectoralis Implant

FDA UDI

Class II (US FDA UDI)

by Hanson Medical, Inc.

Identity

Trade Name
Pectoralis Implant FDA UDI
Generic Name
Pectoral implant, non-sterile FDA UDI
Device Name
Non-sterile, silicone, pectoralis implant, left. FDA UDI
Model / Reference
ACP 2-1 L FDA UDI
Description
Non-sterile, silicone, pectoralis implant, left. FDA UDI

Identifiers

Catalog Number
ACP 2-1 L FDA UDI
Primary DI / UDI-DI
B049ACP21L0 FDA UDI
510(k) Number
K973729 FDA UDI
FDA Product Code
MIC FDA UDI
GMDN Term
Pectoral implant, non-sterile 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

No

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Pectoral implant, non-sterile

Pectoralis Implant by Hanson Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pectoral implant, non-sterile.

Cleared under the same submission

K973729 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hanson Medical, Inc.

Sources (1)

  • FDA UDI 5bd46067-c612-41ae-9aac-464f4907e1a7 36 fields · synced Jun 9, 2026