Puregraft SYNC

Basic Information

• Brand Name: Puregraft SYNC
• Primary DI: 00850034511047
• Version / Model: PURE/SYNC
• Company Name: Bimini Technologies LLC
• Labeler DUNS: 076649467
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-24
• Public Version: 1
• Public Version Date: 2026-03-04
• Public Version Status: New
• Public Device Record Key: 4c836521-7749-4c7b-925e-17128a916469

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: Yes
• 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
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring	General, Plastic Surgery	878.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56627	Autologous adipose tissue noninvasive processing set	A noninvasive collection of non-powered devices designed as a closed system for the collection and processing (e.g., filtering, washing) of autologous fat tissue for reinjection into the patient from whom it was taken (autologous lipotransfer) for aesthetic body contouring. It consists of containers (typically filtration and waste collection bags) and connection accessories (e.g., connectors, tubing); it does not include invasive needles/cannulae. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850034511061	GS1	Box	1	In Commercial Distribution
Primary	00850034511047	GS1

Premarket Submissions

Submission Number	Supplement Number
BK251296	0