FDA Registration
Active
🇺🇸 United States
EnCor Probes
Reg #: 3013041594
·
FEI: 3013041594
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Dymax, Corp.
- Registration Number
- 3013041594
- FEI Number
- 3013041594
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 141 Zehner School Rd
- City
- Zelienople
- State
- PA
- ZIP
- 16063
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093512
Owner / Operator
- Firm Name
- C. R. Bard, Inc.
- Operator Number
- 2212754
- Address
- 1 Becton Drive
- City
- Franklin Lakes
- State
- NJ
- Postal Code
- 07417
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2023-08-07 |
Proprietary Names
EnCor Probes
EnCor Breast Biopsy System Drivers
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)