Puregraft 850 System

GUDID 00850034511207

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

• Primary Device ID: 00850034511207
• NIH Device Record Key: b8b3a05a-bd3b-4fa9-a7d1-513f4a471744
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Puregraft 850 System
• Version Model Number: 850/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 Identifiers

Device Issuing Agency	Device ID
GS1	00850034511191 [Primary]
GS1	00850034511207 [Package]; Contains: 00850034511191; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113255

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

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