Puregraft 50 System

GUDID 00850034511122

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.

Bimini Technologies LLC

Autologous adipose tissue collection/washing set
Primary Device ID00850034511122
NIH Device Record Key8aa9a1aa-e30f-4f08-addf-f416c8623dec
Commercial Distribution StatusIn Commercial Distribution
Brand NamePuregraft 50 System
Version Model Number50/PURE
Company DUNS076649467
Company NameBimini Technologies LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850034511108 [Primary]
GS100850034511122 [Package]
Contains: 00850034511108
Package: Box [5 Units]
In Commercial Distribution

FDA Product Code

MUUSystem, Suction, Lipoplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-11
Device Publish Date2022-04-01

On-Brand Devices [Puregraft 50 System]

00850034511122A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valve
00850034511719A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valve

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