FDA.reportPublic FDA data

SIENTRA Silicone Gel Breast Implant

Primary DI
00812790027149
Brand
SIENTRA Silicone Gel Breast Implant
Company
Sientra, Inc.
Model
20676-310MP
Catalog number
20676-310MP
Device description
Silicone Gel Breast Implant, Textured Shaped Classic Base, Moderate Profile, 310 cc
Published
2023-06-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-FilledGeneral, Plastic Surgery3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P070004008

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P070004008SIENTRA SILICONE GEL BREAST IMPLANTSTiger Aesthetics Medical, LLC2012-03-09FTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812790027149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812790027149008127900271498127900271490812790027149

GMDN Terms#

Term, Definition table
TermDefinition
Silicone gel-filled breast implant, textured-surfaceAn implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel; the shell surface is textured. The implant may vary in shape, profile, volume and shell thickness.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-708-0808customer.experience@sientra.com

Regulatory Flags#

DUNS number
010209877
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810076894621Sientra Viality-1400Viality-1400Viality-14002023-03-13
00812790023196SIENTRA Nasal Implant71-060U71-060U2015-10-23
00812790023202SIENTRA Nasal Implant72-060U72-060U2015-10-23
00812790028191AlloX2 Tissue ExpanderAlloX2-FH11SEAlloX2-FH11SE2020-05-19
00812790028207AlloX2 Tissue ExpanderAlloX2-FH12SEAlloX2-FH12SE2020-05-19
00812790028214AlloX2 Tissue ExpanderAlloX2-FH13SEAlloX2-FH13SE2020-05-19
00812790028221AlloX2 Tissue ExpanderAlloX2-FH14SEAlloX2-FH14SE2020-05-19
00812790028238AlloX2 Tissue ExpanderAlloX2-FH15SEAlloX2-FH15SE2020-05-19
00812790028245AlloX2 Tissue ExpanderAlloX2-FH16SEAlloX2-FH16SE2020-05-19
00812790028252AlloX2 Tissue ExpanderAlloX2-FH11EAlloX2-FH11E2020-05-19
00812790028269AlloX2 Tissue ExpanderAlloX2-FH12EAlloX2-FH12E2020-05-19
00812790028276AlloX2 Tissue ExpanderAlloX2-FH13EAlloX2-FH13E2020-05-19
00812790028283AlloX2 Tissue ExpanderAlloX2-FH14EAlloX2-FH14E2020-05-19
00812790028290AlloX2 Tissue ExpanderAlloX2-FH15EAlloX2-FH15E2020-05-19
00812790028306AlloX2 Tissue ExpanderAlloX2-FH16EAlloX2-FH16E2020-05-19
00812790028313AlloX2 Tissue ExpanderAlloX2-12SEAlloX2-12SE2020-05-19
00812790028320AlloX2 Tissue ExpanderAlloX2-13SEAlloX2-13SE2020-05-19
00812790028337AlloX2 Tissue ExpanderAlloX2-14SEAlloX2-14SE2020-05-19
00812790028344AlloX2 Tissue ExpanderAlloX2-15SEAlloX2-15SE2020-05-19
00812790028351AlloX2 Tissue ExpanderAlloX2-16SEAlloX2-16SE2020-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07445161001702Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001719Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001726Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001733Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001740Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001757Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001764Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001849Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001856Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001863Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001870Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001887Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001894Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001900Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001917Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001924Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001931Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001948Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001955Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001962Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161001979Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002051Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002068Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002075Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002082Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002099Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002105Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002112Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002129Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04
07445161002136Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A.FTR2024-10-04