Pectoralis Implant

Primary DI
B049ACP24RS0
Brand
Pectoralis Implant
Company
Hanson Medical, Inc.
Model
ACP 2-4 R S
Catalog number
ACP 2-4 R S
Device description
Non-sterile, silicone, pectoralis implant, right, sizer.
Published
2015-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MICImplant, Muscle, Pectoralis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MICImplant, Muscle, PectoralisEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973729000POWERFLEX PEC IMPLANTHanson Medical, Inc.1997-12-24MIC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B049ACP24RS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pectoral implant, non-sterileA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(800)771-2215erik@hansonmedical.com

Regulatory Flags#

DUNS number
058759296
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B049N101F0Nasal ImplantN 10-1 FN 10-1 F2015-10-07
B049N101S0Nasal ImplantN 10-1 SN 10-1 S2015-10-07
B049N101W0Nasal ImplantN 10-1 WN 10-1 W2015-10-07
B049N102F0Nasal ImplantN 10-2 FN 10-2 F2015-10-07
B049N102S0Nasal ImplantN 10-2 SN 10-2 S2015-10-07
B049N102W0Nasal ImplantN 10-2 WN 10-2 W2015-10-07
B049N11F0Nasal ImplantN - 11 FN - 11 F2015-10-07
B049N11S0Nasal ImplantN - 11 SN - 11 S2015-10-07
B049N11W0Nasal ImplantN - 11 WN - 11 W2015-10-07
B049N121F0Nasal ImplantN 12-1 FN 12-1 F2015-10-07
B049N121S0Nasal ImplantN 12-1 SN 12-1 S2015-10-07
B049N121W0Nasal ImplantN 12-1 WN 12-1 W2015-10-07
B049N122F0Nasal ImplantN 12-2 FN 12-2 F2015-10-07
B049N122S0Nasal ImplantN 12-2 SN 12-2 S2015-10-07
B049N122W0Nasal ImplantN 12-2 WN 12-2 W2015-10-07
B049N131F0Nasal ImplantN 13-1 FN 13-1 F2015-10-07
B049N131S0Nasal ImplantN 13-1 SN 13-1 S2015-10-07
B049N132F0Nasal ImplantN 13-2 FN 13-2 F2015-10-07
B049N132S0Nasal ImplantN 13-2 SN 13-2 S2015-10-07
B049N133F0Nasal ImplantN 13-3 FN 13-3 F2015-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B4905002016Pectoral ImplantAartMIC2025-08-29
B49050020163Pectoral ImplantAartMIC2025-08-29
B4905002025Pectoral ImplantAartMIC2025-08-29
B4905002026Pectoral ImplantAartMIC2025-08-29
B4905002035Pectoral ImplantAartMIC2025-08-29
B4905002036Pectoral ImplantAartMIC2025-08-29
B4905003015Pectoral ImplantAartMIC2025-08-29
B4905003016Pectoral ImplantAartMIC2025-08-29
B4905003025Pectoral ImplantAartMIC2025-08-29
B4905003026Pectoral ImplantAartMIC2025-08-29
B4905004015Pectoral ImplantAartMIC2025-08-29
B4905004016Pectoral ImplantAartMIC2025-08-29
B4905004025Pectoral ImplantAartMIC2025-08-29
B4905004026Pectoral ImplantAartMIC2025-08-29
B4905004035Pectoral ImplantAartMIC2025-08-29
B4905004036Pectoral ImplantAartMIC2025-08-29
B4905004045Pectoral ImplantAartMIC2025-08-29
B4905004046Pectoral ImplantAartMIC2025-08-29
B4905001015Pectoral ImplantAartMIC2025-08-28
B4905001016Pectoral ImplantAartMIC2025-08-28
B4905001025Pectoral ImplantAartMIC2025-08-28
B4905001026Pectoral ImplantAartMIC2025-08-28
B4905001035Pectoral ImplantAartMIC2025-08-28
B4905001036Pectoral ImplantAartMIC2025-08-28
B4905001045Pectoral ImplantAartMIC2025-08-28
B4905001046Pectoral ImplantAartMIC2025-08-28
B4905001055Pectoral ImplantAartMIC2025-08-28
B4905001056Pectoral ImplantAartMIC2025-08-28
B4905001065Pectoral ImplantAartMIC2025-08-28
B4905001066Pectoral ImplantAartMIC2025-08-28