FDA.reportPublic FDA data

SIENTRA Silicone Gel Breast Implant Sizer

Primary DI
00810076890388
Brand
SIENTRA Silicone Gel Breast Implant Sizer
Company
Sientra, Inc.
Model
GS10712-230MP
Catalog number
GS10712-230MP
Device description
Silicone Gel Sizer, Smooth Round, Moderate Projection, 230 cc
Published
2023-08-14
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
MRDSizer, Mammary, Breast Implant Volume

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRDMammary SizerUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200706000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200706000Sientra OPUS Silicone Gel Breast Implant SizerSientra, Inc.2020-11-16MRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810076890388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810076890388008100768903888100768903880810076890388

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
No natural rubber latex
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
10081317031052MENTOR MemoryGel Enhance Breast ImplantMENTOR TEXAS L.P.MRD2025-04-01
10081317031069MENTOR MemoryGel Enhance Breast ImplantMENTOR TEXAS L.P.MRD2025-04-01
10081317031076MENTOR MemoryGel Enhance Breast ImplantMENTOR TEXAS L.P.MRD2025-04-01
10081317031083MENTOR MemoryGel Enhance Breast ImplantMENTOR TEXAS L.P.MRD2025-04-01
10081317031090MENTOR MemoryGel Enhance Breast ImplantMENTOR TEXAS L.P.MRD2025-04-01
10081317031106MENTOR MemoryGel Enhance Breast ImplantMENTOR TEXAS L.P.MRD2025-04-01
10081317032684MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.MRD2025-04-01
10081317032691MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.MRD2025-04-01
10081317032707MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.MRD2025-04-01
10081317032714MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.MRD2025-04-01
10081317032721MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.MRD2025-04-01
10081317032738MENTOR MemoryGel Enhance Single Use Gel Sizer Ultra High ProfileMENTOR TEXAS L.P.MRD2025-04-01
00810076890319SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890326SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890333SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890340SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890357SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890364SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890371SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890395SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890401SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890418SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890425SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890432SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890449SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890456SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890463SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890470SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890487SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14
00810076890494SIENTRA Silicone Gel Breast Implant SizerSientra, Inc.MRD2023-08-14