Puregraft 850 System Twin Pack

GUDID 00850034511009

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.

Bimini Technologies LLC

Autologous adipose tissue collection/washing set

• Primary Device ID: 00850034511009
• NIH Device Record Key: 6bcd555a-46c0-4348-8b49-6d34fce72a7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Puregraft 850 System Twin Pack
• Version Model Number: 850/TWIN
• 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	00850034511009 [Package]; Contains: 00850034511023; Package: Box [1 Units]; In Commercial Distribution
GS1	00850034511023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK220693

FDA Product Code

• QKL: Lipoaspirate Washing System For Aesthetic Body Contouring

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: 2024-08-30
• Device Publish Date: 2024-08-22

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• 00850034511009 - Puregraft 850 System Twin Pack: 2024-08-30A 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.
• 00850034511009 - Puregraft 850 System Twin Pack: 2024-08-30 A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valves for use in harvesting, filteri
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