Puregraft 250/PURE

GUDID 20863445000301

Puregraft 250 System

PUREGRAFT 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

• Primary Device ID: 20863445000301
• NIH Device Record Key: 0be284d7-a986-4a75-95cb-5e707d1fdfbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Puregraft
• Version Model Number: 250
• Catalog Number: 250/PURE
• Company DUNS: 079508934
• Company Name: PUREGRAFT 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com
• Phone: 858-348-8050
• Email: info@puregraft.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863445000307 [Primary]
GS1	20863445000301 [Package]; Contains: 00863445000307; Package: Case [5 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Puregraft]

• 00863445000345: Puregraft 50 System
• 10863445000311: Puregraft 850 System
• 20863445000301: Puregraft 250 System
• 10860407002222: Puregraft 850 System (Made in USA)
• 10860407002215: Puregraft 250 System (Made in USA)