Singapore HSA registration DE0010930
Davol Simpulse™ SOLO Wound Management System
Singapore·CLASS B·Davol Inc·Registered September 18, 2012Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Orthopaedics
- HSA Product Code
- HSAMDB00110
- HS Code
- 90183990
Registration information
- Registration Number
- DE0010930
- Registration Date
- September 18, 2012
- Change Notification Approval Date
- December 27, 2022
- Retention Due Date
- September 17, 2025
Product description
To provide controlled powered irrigation during open orthopedic and general surgical procedures and for the cleansing of burns or wounds. Appropriate fluids for use include fluids with specific gravity less than 1. The pulsatile action of the pump helps to remove blood, tissue debris and foreign matter from the operative or wound site. When connected to a suction source, the device can be used to aspirate fluids from the operative or wound site.
Product Owner
- Name
- Davol Inc
- Short Name
- Davol
- Address
- 100 Crossing Boulevard, Warwick, RI 02886, UNITED STATES
Registrant
- Address
- 10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
- Address
- 10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model information
- Model Name(s)
- Dual Rgulator with Qick Connect to any nitrogen Dual Regulator adapts 4" Diameter Splash Shield 6 1/2" Diameter Splash Shield Dual Spike Adapter Scjrader-Style Connector dedicates any nitrogen or compressed air outlet DISS Ceiling Outlet adapts Ceiling out for simultaneous DISS Ceiling Outlet adapts Ceiling out for simultaneous 9" Diameter Splash Shield Showerhead Tip, Separable Femoral Tip, Separable Single Orifice Tip, Separable Showerhead Irrigation & Yankauer Suction Tip, Separable Wide Spray Irrigation and Yankauer Suction Tip, Separable Femoral Canal Irrigation Brush (For use with Simpulse™ SOLO Suction Irrigator or Simpulse™ PLUS Suction Irrigator) Simpulse™ SOLO Suction/Irrigator Simpulse™ SOLO System with Soft Splash Shield Tip, Cojoined Suction and Irrigation Tubing, and Dual Spike Adapter Simpulse™ SOLO System with Showerhead Tip, Cojoined Suction and Irrigation Tubing, and Dual Spike Adapter Simpulse™ SOLO System with Femoral Tip. Soft Splash Shield Tip. Suction Tubing and Dual Spike Adapter Showerhead Tip, Separable Single Orifice Tip, Separable Showerhead Irrigation & Yankauer Suction Tip, Separable Wide Spray Irrigation and Yankauer Suction Tip, Separable Multi-Jet High Volume Irrigation and Yankauer Suction Tip, Separable Simpulse™ SOLO Wound Management Kit with VariCare Retractable Splash Shield (1.75" diameter) Wound Tip, Cojoined Suction and Irrigation Tubing, and Dual Spike Adapter Simpulse™ SOLO System with ULTREX Retractable Splash Shield(1.75" diameter) Tip, Cojoined Suction and Irrigation Tubing, and Dual Spike Adapter ULTREX Retractable Small Splash Shield (1.25" diameter) Tip ULTREX Retractable Splash Shield (1.75" diameter) Tip Soft Splash Shield with Showerhead Tip Femoral Canal Tip (For use with Simpulse™ SOLO Suction Irrigator or Simpulse™ PLUS Suction Irrigator) Femoral Canal Tip (Irrigation Only) (For use with Simpulse™ SOLO Suction Irrigator or Simpulse™ PLUS Suction Irrigator) Femoral Canal Brush Femoral Canal Brush with Suction and Irrigation (For use with Simpulse™ SOLO Suction Irrigator or Simpulse™ PLUS Suction Irrigator)
- Model Identifier(s)
- 0037560 0037620 0037630 0037640 0037690 0037700 0037710 0037720 0037740 0057621 0057631 0057651 0057661 0057671 0057900 0067570 0067590 0067600 0067610 0067621 0067651 0067661 0067671 0067681 0067690 0067700 0067710 0067720 0067730 0067740 0067750 0067900 / 0057900 0067910
About this record
Access comprehensive regulatory information for Davol Simpulse™ SOLO Wound Management System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0010930 and owned by Davol Inc. The device was registered on September 18, 2012.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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