Puregraft

Basic Information

• Brand Name: Puregraft
• Primary DI: 00863445000307
• Version / Model: 250
• Catalog Number: 250/PURE
• Company Name: PUREGRAFT LLC
• Labeler DUNS: 079508934
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2023-05-25
• Public Version Status: Update
• Public Device Record Key: 0be284d7-a986-4a75-95cb-5e707d1fdfbe
• Distribution End Date: 2023-05-24

Device Description

Puregraft 250 System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MUU	System, Suction, Lipoplasty	General, Plastic Surgery	878.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56627	Autologous adipose tissue collection/washing set	A collection of sterile devices designed as a closed system for the harvesting and rapid treatment of autologous fat tissue for reinjection back into the patient from which it was taken for aesthetic body contouring. It typically consists of various chambers (e.g., a collection bag, waste material bag, and a cleaned tissue bag), flexible tubing, an intravenous (IV) spike for connection to the washing solutions, and a contiguous filter mesh which dialyses the fat graft. It is used in conjunction with appropriate IV solutions within the sterile field of intervention for plastic and reconstructive surgery and cosmetic surgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20863445000301	GS1	Case	5	Not in Commercial Distribution	2023-05-24
Primary	00863445000307	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092923	000