FDA.reportPublic FDA data

Puregraft Serene Breast Implant

Primary DI
00850034511436
Brand
Puregraft Serene Breast Implant
Company
Bimini Technologies LLC
Model
335CC
Device description
Saline Breast Implant
Published
2024-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FWMProsthesis, Breast, Inflatable, Internal, Saline

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWMProsthesis, Breast, Inflatable, Internal, SalineGeneral, Plastic Surgery3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120011000Puregraft Serene Breast ImplantBimini Health Tech2014-11-14FWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850034511627PackageGS11In Commercial Distribution
00850034511436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850034511627008500345116278500345116270850034511627
00850034511436008500345114368500345114360850034511436

GMDN Terms#

Term, Definition table
TermDefinition
Saline-filled breast implant, internally-structuredA sterile implantable device designed to reconstruct or augment the breast that is composed of a smooth silicone outer shell containing a nested silicone-shell support structure, creating multiple nested lumens inflated with sterile isotonic saline to the desired size. Movement of saline between the lumens is possible through slits and tempered by baffles; the implant has separate fill valves for each lumen and is typically filled with saline before or during the implant procedure.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume335Milliliter

Regulatory Flags#

DUNS number
076649467
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850034511047Puregraft SYNCPURE/SYNC2026-02-24
00850034511023Puregraft 850 System Twin Pack850/TWIN2024-08-22
00850034511108Puregraft 50 System50/PURE2022-04-01
00850034511139Puregraft 250 System250/PURE2022-04-01
00850034511177Puregraft 250 System250/PURE2022-04-01
00850034511191Puregraft 850 System850/PURE2022-04-01
00850034511696Puregraft 50 System50/PURE2024-01-11
00850034511252Dermapose RefreshREFRESH2022-02-09
00850034511276AutoPose RestoreABS-101035-12022-02-09
00850034511993DIRECT2 LidPVL/PURE22024-10-04
00850034511009Puregraft 850 System Twin Pack850/TWIN2024-08-22
00850034511092Puregraft Serene Breast Implant210CC2024-03-28
00850034511283Puregraft Serene Breast Implant270CC2024-03-28
00850034511368Puregraft Serene Breast Implant300CC2024-03-28
00850034511641Puregraft Serene Breast Implant370CC2024-03-28
00850034511665Puregraft Serene Breast Implant405CC2024-03-28
00850034511689Puregraft Serene Breast Implant440CC2024-03-28
00850034511764Puregraft Serene Breast Implant475CC2024-03-28
00850034511788Puregraft Serene Breast Implant515CC2024-03-28
00850034511818Puregraft Serene Breast Implant555CC2024-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10081317028687MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
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10081317028700MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028717MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028724MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028731MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028748MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028755MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028762MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028779MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028786MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028793MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028809MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028816MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028823MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028830MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028847MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028854MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028861MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028939MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028946MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028953MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028960MENTOR Smooth Round High ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028977MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028984MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028991MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317029004MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317029011MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317029028MENTOR Smooth Round Moderate ProfileMENTOR TEXAS L.P.FWM2025-03-17