FDA Registration
Active
🇺🇸 United States
16 Vial Prostate Biopsy Kit (CS/20)
Reg #: 3006450277
·
FEI: 3006450277
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- THERAPAK, LLC
- Registration Number
- 3006450277
- FEI Number
- 3006450277
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4305 Hamilton Mill Rd Ste 200
- City
- BUFORD
- State
- GA
- ZIP
- 30518
- Country
- US
Owner / Operator
- Firm Name
- Therapak, LLC
- Operator Number
- 9002081
- Address
- 651 Wharton Drive
- City
- Claremont
- State
- CA
- Postal Code
- 91711
- Country
- US
- Correspondent
- Jason Gumaer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Biopsy, Without Biopsy Instruments | FCH | Class 1 | Gastroenterology, Urology | No | 2014-05-02 |
Proprietary Names
16 Vial Prostate Biopsy Kit (CS/20)
8-Vial Prostate Biopsy Transport Kit, 30/case
Prostate Biopsy - Histology Cassette Transport Kit (CS/20)
Generic 12-Vial Prostate Biopsy Transport Kit (CS/30)
14 Vial Prostate Biopsy Transport Kit (CS/20)
GI Biopsy Kit, 2 Vial 20/CS
Establishment Types
Manufacture Medical Device