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 Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set

Primary Device ID	00850034511245
NIH Device Record Key	12000cd4-6113-493e-b878-fa42e037ae6b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Puregraft 250 System
Version Model Number	250/PURE
Company DUNS	076649467
Company Name	Bimini Technologies LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter
Total Volume	250 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850034511177 [Primary]
GS1	00850034511184 [Package] Contains: 00850034511177 Package: Box [1 Units] In Commercial Distribution
GS1	00850034511245 [Package] Contains: 00850034511177 Package: Box [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K092923

FDA Product Code

MUU	System, Suction, Lipoplasty

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-04-11
Device Publish Date	2022-04-01

On-Brand Devices [Puregraft 250 System]

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