FDA.reportPublic FDA data

Q-graft collector

Primary DI
04260170881113
Brand
Q-graft collector
Company
Human Med AG
Model
Single-use Q-graft collector
Catalog number
300001
Device description
Q-graft collector, single-use, for collection of regenerative cells (stromal vascular fraction/ SVF) from adipose tissue
Published
2025-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260170881106PackageGS15In Commercial Distribution
04260170881113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260170881106042601708811064260170881106
04260170881113042601708811134260170881113

GMDN Terms#

Term, Definition table
TermDefinition
Stromal vascular fraction recovery setA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature8 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature8 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+49385395700info@humanmed.com

Regulatory Flags#

DUNS number
332719157
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260170880048WAL applicatorSingle-use WAL Applicator for body-jet, L=300500001-52025-07-30
04260170880505WAL applicatorSingle-use WAL Applicator, Short, L=300, for 20 cm500001K-52025-07-30
04260170880826WAL CannulaSingle-use, Ø=3.8, L=300, 4H, Extraction1500125-52025-07-30
04260170880864WAL CannulaSingle-use, Ø=4.8, L=300, 4H, Extraction1500136-52025-07-30
04260170880888WAL CannulaSingle-use, Ø=4.2, L=300, 4H, Extraction1500148-52025-07-30
04260170880901WAL CannulaSingle-use, Ø=3.8, L=300, 4H, Extraction1501125-52025-07-30
04260170880925WAL CannulaSingle-use, Ø=3.8, L=300, 3H, Extraction, Subcutan1502004-52025-07-30
04260170880949WAL CannulaSingle-use, Ø=3.8, L=300, 8H, Extraction1503004-52025-07-30
04260170880963WAL CannulaSingle-use, Ø=4.8, L=300, 8H, Extraction1503005-52025-07-30
04260170881007Biofill CannulaSingle-use, Ø=3.5, L=150, 4H, Extraction1580089-52025-07-30
04260170881021Biofill Infiltration CannulaSingle-use, Ø=2.5, L=150, 0H, Infiltration1580107-52025-07-30
04260170881045Biofill CannulaSingle-use, Ø=3.8, L=150, 4H, Extraction1580125-52025-07-30
04260170881069Biofill CannulaSingle-use, Ø=3.8, L=150, 4H, Rapid, Extraction1581125-52025-07-30
04260170881083FillerCollectorSingle-use FillerCollector, 250ml, Collect Fat1660000-52025-07-30
04260170881137WAL Infiltration CannulaSingle-use, Ø=2.5, L=200, 0H, 180°, Infiltration1500114-52025-07-30
04260170881144WAL applicator, 370 cmSingle-use WAL Applicator for body-jet evo, L=370,570001-52025-07-30
04260170881151Biofill applicatorSingle-use Biofill Applicator for body-jet evo and580001-52025-07-30
04260170881373Disposable Set FillerCollectorSingle-use Disposable Set for Re-usable FillerColl6600232025-07-30
04260170881403Disposable Set LipoCollector IIISingle-use Disposable Set for Re-usable LipoCollec6702002025-07-30
04260170881410Drainage Set LipoCollector III Plusingle-use Drainage Set for Re-usable LipoCollector6713002025-07-30

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