FDA UDI
In Commercial Distribution
🇺🇸 United States
Selphyl PRP Tube
DI: 00851802007113
·
Model: 0363
·
Factor Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Selphyl PRP Tube
- Primary DI
- 00851802007113
- Version / Model
- 0363
- Catalog Number
- 0363
- Company Name
- Factor Medical, Inc.
- Labeler DUNS
- 117697569
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-03
- Public Version
- 1
- Public Version Date
- 2024-08-12
- Public Version Status
- New
- Public Device Record Key
- b60e65f6-1339-4a70-bac7-08e032f932d8
Device Description
Blood separation tube for PRP
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
- Yes
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 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 | 00851802007113 | GS1 |
Customer Contacts
- Phone
- 6103171670
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK170096 | 0 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 9 | Milliliter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius