AccessGUDID - DEVICE: Q-graft collector (04260170881113)

GUDID

Device Identifier (DI) Information

Brand Name: Q-graft collector
Version or Model: Single-use Q-graft collector
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 300001
Company Name: Human Med AG

Primary DI Number: 04260170881113
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332719157 *Terms of Use

Device Description: Q-graft collector, single-use, for collection of regenerative cells (stromal vascular fraction/ SVF) from adipose tissue

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 8 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 8 and 40 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a689f8d7-4af0-48af-8d4f-c97ebb2a896d
Public Version Date: August 07, 2025
Public Version Number: 1
DI Record Publish Date: July 30, 2025