FDA.reportPublic FDA data

Puregraft 850 System Twin Pack

Primary DI
00850034511009
Brand
Puregraft 850 System Twin Pack
Company
Bimini Technologies LLC
Model
850/TWIN
Device description
A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valves for use in harvesting, filtering, and transferring autologous fat tissue for reinjecting back into the same patient. Two bags included per packaging unit.
Published
2024-08-22
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
QKLLipoaspirate Washing System For Aesthetic Body Contouring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKLLipoaspirate Washing System For Aesthetic Body ContouringGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK2206930

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2206930

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850034511009PackageGS11In Commercial Distribution
00850034511023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850034511009008500345110098500345110090850034511009
00850034511023008500345110238500345110230850034511023

GMDN Terms#

Term, Definition table
TermDefinition
Autologous adipose tissue collection/washing setA collection of sterile devices designed as a closed system for the harvesting and rapid treatment of autologous fat tissue for reinjection back into the patient from which it was taken for aesthetic body contouring. It typically consists of various chambers (e.g., a collection bag, waste material bag, and a cleaned tissue bag), flexible tubing, an intravenous (IV) spike for connection to the washing solutions, and a contiguous filter mesh which dialyses the fat graft. It is used in conjunction with appropriate IV solutions within the sterile field of intervention for plastic and reconstructive surgery and cosmetic surgery. This is a single-use device.

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
true
Serial number
false
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
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
00850034511818Puregraft Serene Breast Implant555CC2024-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08681877009017Lipocube NanoSTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009086Centrifgue Container (15CC)STEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009093Centrifgue Container (20 CC) STEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009116Lipocube HybridSTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009345Lipocube Hybrid ISTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009826Lipocube Hybrid MiniSTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
00850034511047Puregraft SYNCBimini Technologies LLCQKL2026-02-24
04260170881083FillerCollectorHuman Med AGQKL2025-07-30
04260170881373Disposable Set FillerCollectorHuman Med AGQKL2025-07-30
04260170881403Disposable Set LipoCollector IIIHuman Med AGQKL2025-07-30
04260170881410Drainage Set LipoCollector III PlusHuman Med AGQKL2025-07-30
04260170881427Extraction cannula, LCHuman Med AGQKL2025-07-30
04260170881434Extraction cannulaHuman Med AGQKL2025-07-30
04260170881441Extraction cannulaHuman Med AGQKL2025-07-30
04260170881502Extraction tubeHuman Med AGQKL2025-07-30
04260170881571FillerCollector, Stand, SU, SetHuman Med AGQKL2025-07-30
04260170881076FillerCollectorHuman Med AGQKL2025-07-30
04260170881366FillerCollectorHuman Med AGQKL2025-07-30
14260170881370Disposable Set FillerCollectorHuman Med AGQKL2025-07-30
04260170881380LipoCollector 3, completeHuman Med AGQKL2025-07-30
14260170881400Disposable Set LipoCollector IIIHuman Med AGQKL2025-07-30
14260170881417Drainage Set LipoCollector III PlusHuman Med AGQKL2025-07-30
14260170881424Extraction cannula, LCHuman Med AGQKL2025-07-30
14260170881431Extraction cannulaHuman Med AGQKL2025-07-30
14260170881448Extraction cannulaHuman Med AGQKL2025-07-30
14260170881509Extraction tubeHuman Med AGQKL2025-07-30
14260170881578FillerCollector, Stand, SU, SetHuman Med AGQKL2025-07-30
00860005496709SyntrFuge SystemSyntr Health Technologies, IncQKL2024-10-17
00860005496723SyntrFuge System 30Syntr Health Technologies, IncQKL2024-10-17
00850034511023Puregraft 850 System Twin PackBimini Technologies LLCQKL2024-08-22