FDA Registration
Active
🇺🇸 United States
Dymax, Corp.
Reg #: 3013041594
·
FEI: 3013041594
·
Expires 2026
Products
12
Proprietary Names
27
Establishment Types
3
Classifications
12
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Registration Details
- Registration Name
- Dymax, Corp.
- Registration Number
- 3013041594
- FEI Number
- 3013041594
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 141 Zehner School Rd
- City
- Zelienople
- State
- PA
- ZIP
- 16063
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182281
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 |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2009-08-26 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2012-07-10 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2012-07-10 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2014-01-23 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2016-09-07 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2018-11-21 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2009-01-08 |
| Disinfectant, Medical Devices | LRJ | Class 1 | General Hospital | No | 2020-10-28 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2014-01-09 |
| Urinometer, Electrical | EXS | Class 2 | Gastroenterology, Urology | No | 2012-02-24 |
| Collector, Urine, Powered, Non Indwelling Catheter | NZU | Class 1 | Gastroenterology, Urology | No | 2018-01-10 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2026-03-26 |
Proprietary Names
Positioning System Stylet
Sherlock 3CG Tip Positioning System
Sensor & Sherlock 3CG Tip
Arctic Sun Temperature Management System
Vacora Vacuum Assisted Biopsy Sys
Arctic Sun Cleaning Solution
Bard Dual Connector to 3.5 mm Plug 12' Monitor Cable
Sensica UO System
Bard CritiCore
Site-Rite Needle Guide Kits and Pro
EnCor Breast Biopsy System - EnCor Probes, Drivers, and Accessories
EnCor Breast Biopsy System
Arctic Sun Stat Temperature Management System
EnCor Ultra Breast Biopsy System and Accessories
EnCor Enspire Breast Biopsy System and Accessories
Vacuum Tubing
Patient Tubing
PureWick FEC
Collection Canister
PureWick Urine Collection Accessories Kit
PureWick Urine Collection System
PureWick MEC
PureWick Male External Catheter
PureWick Female External Catheter
Arctic Sun Temperature Management System (Model 5000)
Elyra Thulium Laser Fibers
Elyra Thulium Fiber Laser System and Accessories
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Remanufacture Medical Device
Repack or Relabel Medical Device