FDA UDI
In Commercial Distribution
🇺🇸 United States
RegenPlasma/RegenKit-Woud Gel-2
DI: 07640138981616
·
Model: RK-WG-2
·
REGEN LAB SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RegenPlasma/RegenKit-Woud Gel-2
- Primary DI
- 07640138981616
- Version / Model
- RK-WG-2
- Company Name
- REGEN LAB SA
- Labeler DUNS
- 482206518
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-19
- Public Version
- 1
- Public Version Date
- 2023-01-27
- Public Version Status
- New
- Public Device Record Key
- 9300c9f3-5f54-4b54-b792-7935d2fac1eb
Device Description
The RegenKit®-Wound Gel-2 contains 2 RegenWound PRP Tubes and 1 RegenWound ATS Tube. INTENDED USE / INDICATIONS FOR USE RegenKit®-Wound Gel-2 is designed to be used at point-of-care for the safe and rapid preparation of platelet-rich plasma (PRP) gel (RegenWound Gel) from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the RegenWound Gel is topically applied for the management of exuding cutaneous wounds, such as leg ulcers, pressure ulcers and diabetic ulcers, and mechanically or surgically debrided wounds.
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
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| PMQ | Peripheral Blood Processing Device For Wound Management | Hematology | 864.9245 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46923 | Haematological concentrate system preparation kit, platelet concentration | A collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640138981616 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius