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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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PENTAX LED Light Source BS-LL Series
HOYA CORPORATION
BS-LL1
In Commercial Distribution

  • 04961333227259 ()
  • 04961333228942 ()


  • Endoscopic light source unit, battery-powered
LED Portable Light Source
OPTIM LLC
F0063873L1
In Commercial Distribution

  • 00858119004101 ()


  • Endoscopic light source unit, battery-powered
LED light source, red
STRYKER CORPORATION
PRLS-100
In Commercial Distribution

  • 00857326005581 ()
  • 10857326005588 ()


  • Endoscopic light source unit, battery-powered
The Genesis RapidWeld II STW, model GRW-430-02, is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430-02
In Commercial Distribution

  • 00866305000264 ()

  • Length: 33 Centimeter
  • Height: 9.9 Centimeter
  • Width: 14.2 Centimeter
  • Weight: 2.5 Kilogram
480-RW-2607-02

  • Laboratory tubing welder
The TCD B40 is a bench top, portable device intended for use by appropriately trained and qualified personnel in hospital/laboratory/clinical settings for the purpose of making sterile connections of 3.9 mm to 4.5 mm PVC tubing in blood processing applications.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 00866305000219 ()

  • Weight: 1.6 Kilogram
  • Width: 9.1 Centimeter
  • Length: 27.2 Centimeter
  • Height: 5.9 Centimeter
480-B40-00-1245

  • Laboratory tubing welder
The Genesis Rapid Weld STW is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 00866305000202 ()

  • Weight: 2.5 Kilogram
  • Width: 14.2 Centimeter
  • Height: 9.9 Centimeter
  • Length: 33 Centimeter
480-RW-2607-00

  • Laboratory tubing welder
Compact handheld light source (battery operated)
Firefly Global
ES201
In Commercial Distribution

  • 00851289007002 ()


  • Endoscopic light source unit, battery-powered
No Description
COGENTIX MEDICAL, INC.
BLS-1000
In Commercial Distribution

  • 00874485000318 ()
07-3050

  • Endoscopic light source unit, battery-powered
No Description
Happersberger Otopront GmbH
OTOLUX-LED
In Commercial Distribution

  • 04260154546731 ()


  • Endoscopic light source unit, battery-powered
The TCDB40 Wafer Assembly consists of a copper wafer and plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion. The wafer assembly is placed in the TCDB40 Sterile Tube Welding device prior to the weld process. The copper wafer is separated from the plastic holder during the welding process and after welding is completed both the plastic holder and the copper wafer are removed from the device and discarded. The wafers are single use only and cannot be reused. The TCDB40 Sterile Tube Welding device will not operate without a wafer assembly inserted and will not operate with a used a wafer. The TCDB40 wafer assemblies are packaged in 8 plastic trays. Each tray has 25 individual wafer assemblies. Each box referred to as a case has a total of 200 individual TCDB40 wafer assemblies.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 10866305000278 ()
  • 00866305000271 ()
480-B40-00-2038

  • Laboratory tubing welder
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