FDA.reportPublic FDA data

Puregraft Serene Breast Implant

Primary DI
00850034511894
Brand
Puregraft Serene Breast Implant
Company
Bimini Technologies LLC
Model
635CC
Device description
Saline Breast Implant
Published
2024-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00850034511894PackageGS11In Commercial Distribution
00850034511870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850034511894008500345118948500345118940850034511894
00850034511870008500345118708500345118700850034511870

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 Volume635Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
076649467
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850034511436Puregraft Serene Breast Implant335CC2024-03-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10081317028670MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028687MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
10081317028694MENTOR Smooth Round Moderate Plus ProfileMENTOR TEXAS L.P.FWM2025-03-17
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