Q-graft control device

Basic Information

• Brand Name: Q-graft control device
• Primary DI: 04260170881090
• Version / Model: Q-graft control device
• Catalog Number: 300000
• Company Name: Human Med AG
• Labeler DUNS: 332719157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-30
• Public Version: 1
• Public Version Date: 2025-08-07
• Public Version Status: New
• Public Device Record Key: 5bc3f18b-7dad-4873-8046-647208c2d4e7

Device Description

Q-graft control, Q-graft system for the intraoperative separation and collection of regenerative cells (stromal vascular fraction/ SVF) from adipose tissue

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47501	Stromal vascular fraction recovery set	A collection of disposable devices intended to be used to obtain a stromal vascular fraction (SVF) [stem and regenerative cells from the adipose tissue of a patient] immediately following tissue harvesting. It typically consists of a plastic collection container, centrifuge processing and concentration chambers, waste bags, and tubing that functions in combination with a proteolytic enzyme and an electromechanical unit to digest adipose tissue and subsequently wash and concentrate its stem and regenerative cells. The SVF is typically used in surgical (e.g., plastic and reconstructive, orthopaedic) or disease treatment (e.g., cardiovascular) applications. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260170881090	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius