FDA UDI
In Commercial Distribution
🇺🇸 United States
Illuminate PRP
DI: 00860012982103
·
Model: ILLU-PRP-22
·
GALE FORCE AESTHETICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Illuminate PRP
- Primary DI
- 00860012982103
- Version / Model
- ILLU-PRP-22
- Company Name
- GALE FORCE AESTHETICS, LLC
- Labeler DUNS
- 113170269
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-12
- Public Version
- 1
- Public Version Date
- 2025-02-20
- Public Version Status
- New
- Public Device Record Key
- 7c322830-7869-4f0b-b167-bcb79ea3a011
Device Description
Polyester gel media containing, vacuum evacuated tube that is intended for separating and concentrating blood components along with the use of a centrifuge system. Sterile, Single-use
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| ORG | Platelet And Plasma Separator For Bone Graft Handling | Hematology | 864.9245 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47183 | Haematological concentrate system | An assembly of devices typically used at the point-of-care to concentrate platelets or bone marrow aspirate cells, through low-speed centrifugal force (e.g., 2,500 to 7,000 rpm), from a small volume of a patient's own blood/bone marrow for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). It typically consists of a centrifuge, a dedicated centrifuge tube(s) and sample collection/processing kits, a concentrate delivery unit, and various disposable applicators. After processing, the concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10860012982100 | GS1 | 1 | 1 | In Commercial Distribution | |
| Primary | 00860012982103 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK241042 | 0 |