FDA UDI
In Commercial Distribution
🇺🇸 United States
Q-graft centrifugation set
DI: 04260170881618
·
Model: Single-use Centrifugation Set for Q-graft
·
Human Med AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Q-graft centrifugation set
- Primary DI
- 04260170881618
- Version / Model
- Single-use Centrifugation Set for Q-graft
- Catalog Number
- 300003
- 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
- 358e37fd-8fdc-4000-b248-89441c110538
Device Description
Q-graft centrifugation set, for the intraoperative separation of regenerative cells (stromal vascular fraction/ SVF) from adipose tissue
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 14260170881615 | GS1 | cardboard box | 5 | In Commercial Distribution | |
| Primary | 04260170881618 | GS1 |
Customer Contacts
- Phone
- +49385395700
- [email protected]