FDA UDI
In Commercial Distribution
🇺🇸 United States
Eclipse PRP HC
DI: 00853602008093
·
Model: PRP2000-1.Intl
·
ECLIPSE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Eclipse PRP HC
- Primary DI
- 00853602008093
- Version / Model
- PRP2000-1.Intl
- Catalog Number
- PRP2000-1.Intl
- Company Name
- ECLIPSE
- Labeler DUNS
- 969752364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-04
- Public Version
- 1
- Public Version Date
- 2018-11-05
- Public Version Status
- New
- Public Device Record Key
- 88577d12-32b0-4468-a41b-bb0d49f5704b
Device Description
Eclipse PRP HC Patient Kit - 22ml PRP Tube Only (International)
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00853602008093 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK110035 | 0 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 123.8 | Gram | |
| Depth | 1.125 | Inch | |
| Width | 6.938 | Inch | |
| Height | 3.125 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius