Puregraft 250 System

GUDID 00850034511245

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 ID00850034511245
NIH Device Record Key12000cd4-6113-493e-b878-fa42e037ae6b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePuregraft 250 System
Version Model Number250/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 Dimensions

Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter
Total Volume250 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850034511177 [Primary]
GS100850034511184 [Package]
Contains: 00850034511177
Package: Box [1 Units]
In Commercial Distribution
GS100850034511245 [Package]
Contains: 00850034511177
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 250 System]

00850034511245A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valve
00850034511146A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valve

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