FDA.reportPublic FDA data

Gluteal Implant

Primary DI
B049ACP61R0
Brand
Gluteal Implant
Company
Hanson Medical, Inc.
Model
ACP 6-1 R
Catalog number
ACP 6-1 R
Device description
Non-sterile, silicone, gluteal implant, right.
Published
2015-10-12
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
MIBElastomer, Silicone Block

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIBElastomer, Silicone BlockEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030809000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030809000HANSON MEDICAL GLUTEAL IMPLANTHanson Medical, Inc.2003-04-21MIB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B049ACP61R0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Silicone-block tissue reconstructive materialA non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-section or with curved surfaces. It may be carved or trimmed into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that involve soft-tissue or bone augmentation, or the formation of prosthetic implants (e.g., chin or malar). This is a single-use device.

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
M724CCB5SIZ7NS1ContourFlex™ Gluteal Implant Sizer RoundIMPLANTECH ASSOCIATES, INC.MIB2024-05-20
M724CCB11SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB12SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB13SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB14SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB15SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB21SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB22SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB23SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB31SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB32SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB33SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB41SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB42SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB43SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB44SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB45SIZNS1Contoured Carving Block SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZK1NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZNC1NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB5SIZNC3NS1ContourFlex™ Gluteal Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB7SIZ1NS1ContourFlex™ Calf Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB7SIZ3NS1ContourFlex™ Calf Implant SizerIMPLANTECH ASSOCIATES, INC.MIB2017-10-17
M724CCB50NS1ContourFlex™ Gluteal ImplantIMPLANTECH ASSOCIATES, INC.MIB2017-07-10
M724CCB45NS1Contoured Carving BlockIMPLANTECH ASSOCIATES, INC.MIB2016-04-22
M72423700071AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700101AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700151AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700201AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700301AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24
M72423700401AlliedSil™ SheetingIMPLANTECH ASSOCIATES, INC.MIB2015-09-24