AuraGen Aesthetics

GUDID 00860003492703

Lipoaspirate Wash System

Auragen Aesthetics 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 Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set

• Primary Device ID: 00860003492703
• NIH Device Record Key: 1f8b7c70-9ab4-430f-92cf-f14f55ca0330
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AuraGen Aesthetics
• Version Model Number: 100358
• Company DUNS: 118060681
• Company Name: Auragen Aesthetics 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003492703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK190433

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: 2021-07-13
• Device Publish Date: 2021-07-05