FDA Registration
Active
🇺🇸 United States
Genesis PRP
Reg #: 3010392991
·
FEI: 3010392991
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- BELLUS MEDICAL, LLC
- Registration Number
- 3010392991
- FEI Number
- 3010392991
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 207 Mockingbird Ln
- City
- Johnson City
- State
- TN
- ZIP
- 37604
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK170136
Owner / Operator
- Firm Name
- Bellus Medical, LLC
- Operator Number
- 10044925
- Address
- 207 Mockingbird Lane
- City
- Johnson City
- State
- TN
- Postal Code
- 37604
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2019-04-29 |
Proprietary Names
Genesis PRP
Healeon HD PRP
ProGen PRP Eclipse
BTR PRP
Gold Rush PRP
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility