FDA UDI
In Commercial Distribution
🇺🇸 United States
Dr.PRP
DI: 08809410200046
·
Model: Dr.PRP-30
·
Rmedica Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Dr.PRP
- Primary DI
- 08809410200046
- Version / Model
- Dr.PRP-30
- Company Name
- Rmedica Co.,Ltd
- Labeler DUNS
- 694634708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-02
- Public Version
- 1
- Public Version Date
- 2026-02-10
- Public Version Status
- New
- Public Device Record Key
- 8e30332f-077b-4bc1-b2bf-31cb57396b94
Device Description
The Dr.PRP-30 is an individually packaged sterile, single-use, disposable concentrating unit composed of medical-grade polymer and elastomer. The concentrating unit has a 30ml volume capacity and is designed to work with a single rotor-type general-purpose centrifuge.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 | 08809410200053 | GS1 | Inner box | 8 | In Commercial Distribution | |
| Primary | 08809410200046 | GS1 |
Customer Contacts
- Phone
- +8228532926
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 35.6 – 86 Degrees Fahrenheit