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
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
Transducer, Ultrasonic, Diagnostic ITX
System, Imaging, Pulsed Echo, Ultrasonic IYO
Stand, Infusion FOX
System, Thermal Regulating DWJ
System, Image Processing, Radiological LLZ
Instrument, Biopsy KNW
Disinfectant, Medical Devices LRJ
System, Imaging, Pulsed Doppler, Ultrasonic IYN
Urinometer, Electrical EXS
Collector, Urine, Powered, Non Indwelling Catheter NZU
Powered Laser Surgical Instrument GEX

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