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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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
LED light source, red
STRYKER CORPORATION
PRLS-100
In Commercial Distribution

  • 00857326005581 ()
  • 10857326005588 ()


  • Endoscopic light source unit, battery-powered
Portable LED Light Source, Storz adapter, (includes rechargeable battery and charger)
BR Surgical, LLC
BR900-7400
In Commercial Distribution

  • 00840183500474 ()
BR900-7400

  • 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
The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000254 ()
  • 00866305000257 ()
480-RW-2478-03

  • Laboratory tubing welder
The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000247 ()
  • 00866305000240 ()
480-RW-2478-02

  • Laboratory tubing welder
The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis RapidWeld STW, Model GRW-430 will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000230 ()
  • 00866305000233 ()
480-RW-2478-01

  • Laboratory tubing welder
The TCD B40 Wafer Assembly consists of a copper wafer and a plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion.The wafer assembly is placed in the device prior to the weld process. During the welding process the copper wafer is separated from the plastic holder, and after welding is completed, both the holder and wafer are removed from the device and discarded. The wafers are one-time use only and cannot be reused. The TCD B40 device will not operate without a wafer assembly inserted and will not operate with a used wafer. The TCD B40 wafer assemblies are packaged in boxes containing 240 wafer assemblies in each box referred to as a case.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 10866305000223 ()
  • 00866305000226 ()
480-B40-00-1274

  • Laboratory tubing welder
LED Light Source, Storz Connection
MARINA MEDICAL INSTRUMENTS, INC.
250-800
In Commercial Distribution

  • 00840306825132 ()
250-800

  • Endoscopic light source unit, battery-powered
Battery Light Source LED fast screw
Karl Storz GmbH & Co. KG
11301DF
In Commercial Distribution

  • 04048551050798 ()


  • Endoscopic light source unit, battery-powered
Battery Light Source LED, click connect.
Karl Storz GmbH & Co. KG
11301DE
In Commercial Distribution

  • 04048551050781 ()


  • Endoscopic light source unit, battery-powered
Light source "EndoLED", for flexible endoscopes
OLYMPUS Winter & Ibe GmbH
WA91502A
In Commercial Distribution

  • 04042761073592 ()
WA91502A

  • Endoscopic light source unit, battery-powered
Light source "EndoLED", for rigid endoscopes
OLYMPUS Winter & Ibe GmbH
WA91500A
In Commercial Distribution

  • 04042761070010 ()
WA91500A

  • Endoscopic light source unit, battery-powered
The CompoDock is used for the production of special cellular blood components, e.g. in blood banks where tube connections are needed that provide protection against microbial contamination. The CompoDock is a high-frequency connection device that permits sterile connection of medical PVC tubes to one another. Here, sterile connection is achieved when germs from the environment are prevented from being carried into the closed systems. The closed system is maintained after the docking process.
Fresenius Kabi AG
9028721
In Commercial Distribution

  • 04086000860215 ()
9028721

  • Laboratory tubing welder
No Description
Happersberger Otopront GmbH
OTOLUX-LED
In Commercial Distribution

  • 04260154546731 ()


  • Endoscopic light source unit, battery-powered
LED Stroboscopy Light Source
Karl Storz GmbH & Co. KG
40160021
In Commercial Distribution

  • 04048551242506 ()


  • Endoscopic light source unit, battery-powered
Battery Light Source LED fast screw
Karl Storz GmbH & Co. KG
11301D4
In Commercial Distribution

  • 04048551226797 ()


  • Endoscopic light source unit, battery-powered
Battery Light Source LED, coarse thread
Karl Storz GmbH & Co. KG
11301D3
In Commercial Distribution

  • 04048551226773 ()


  • Endoscopic light source unit, battery-powered
Battery Light Source LED Fine Screw
Karl Storz GmbH & Co. KG
11301D1
In Commercial Distribution

  • 04048551226735 ()


  • Endoscopic light source unit, battery-powered
Pen-LED-light for Sapi Med anoscopes, rectoscopes and retractors.
SAPI MED SPA
Pen LED light
In Commercial Distribution

  • 08033638801055 ()
  • 08033638801048 ()
B.0306

  • Endoscopic light source unit, battery-powered
The Hand Sealer is used to provide a hermetic closure on Blood-Pack Unit tubings when used with the Fenwal Hand Sealer Clips, code 4R4418.
Fresenius Kabi AG
4R4454W
In Commercial Distribution

  • 00810020441062 ()
4R4454W

  • Laboratory tubing welder
Sterile Tube Welder
Wuhan BMS Medicaltech Co., Ltd
STW6810-RFID
In Commercial Distribution

  • 06976052440092 ()


  • Laboratory tubing welder
Metal Wire Cassette is a disposable part of Sterile Tube Welder
Wuhan BMS Medicaltech Co., Ltd
Metal Wire Cassette
In Commercial Distribution

  • 16976052440068 ()
  • 06976052440061 ()


  • Laboratory tubing welder
Rover IV Portable LED Light Source Complete with Charger and Batteries
Mytamed, Inc.
mV-LLS-4LBTP
Not in Commercial Distribution

  • B351MVLLS4LBTP0 ()
mV-LLS-4LBTP

  • Endoscopic light source unit, battery-powered
No Description
W.O.M. World of Medicine GmbH
Z1415-01
In Commercial Distribution

  • 04056702000080 ()


  • Laparoscopic insufflator
Custom Rounded Corner Klarity Cushion™ for Head Support, 15x20cm for Eberhard Medizintechnik
Klarity Medical Products, LLC
R550-CVS
In Commercial Distribution

  • 00817355023420 ()


  • Patient positioning thermoplastic mould material
Shani Darden Branded Facemask Blue, Red & NIR facemask
I-SMART DEVELOPMENTS LIMITED
TN2118
In Commercial Distribution

  • 05060534510517 ()
115-HGSD

  • Blue/red/infrared phototherapy lamp
MZ Skin Mask: MZ Skin LightMAX Supercharged LED Mask 2.0
I-SMART DEVELOPMENTS LIMITED
TN2025
In Commercial Distribution

  • 05060534510418 ()
140-MZ

  • Blue/red/infrared phototherapy lamp
EOS X by Deesse Pro Blue, Red, Green & NIR facemask indicated for Acne and Wrinkles.
I-SMART DEVELOPMENTS LIMITED
TN2214
In Commercial Distribution

  • 05060534510401 ()


  • Blue/red/infrared phototherapy lamp
PB107-PARAFFIN BATH 220V U.K. CORD
Whitehall Manufacturing Co
PB-107B-CORD2
In Commercial Distribution

  • 00645724004141 ()
PB107BCORD2

  • Physical therapy paraffin wax bath
PB105-PARAFFIN BATH 220V RUSSIAN CORD
Whitehall Manufacturing Co
PB-105B-CORD6
In Commercial Distribution

  • 00645724004110 ()
PB105BCORD6

  • Physical therapy paraffin wax bath
PB105-PARAFFIN BATH 220V POWER CORD
Whitehall Manufacturing Co
PB-105B-CORD5
In Commercial Distribution

  • 00645724004103 ()
PB105BCORD5

  • Physical therapy paraffin wax bath
PB105-PARAFFIN BATH 220V U.K. CORD
Whitehall Manufacturing Co
PB-105B-CORD2
In Commercial Distribution

  • 00645724004073 ()
PB105BCORD2

  • Physical therapy paraffin wax bath
PB105-PARAFFIN BATH 220V EUROPEAN CORD
Whitehall Manufacturing Co
PB-105B-CORD1
In Commercial Distribution

  • 00645724004066 ()
PB105BCORD1

  • Physical therapy paraffin wax bath
PB104-PARAFFIN BATH 220V INDIA/S.A. CORD
Whitehall Manufacturing Co
PB-104B-CORD7
In Commercial Distribution

  • 00645724004059 ()
PB104BCORD7

  • Physical therapy paraffin wax bath
PB104-PARAFFIN BATH 220V RUSSIAN CORD
Whitehall Manufacturing Co
PB-104B-CORD6
In Commercial Distribution

  • 00645724004042 ()
PB104BCORD6

  • Physical therapy paraffin wax bath
PB104-PARAFFIN BATH 220V POWER CORD
Whitehall Manufacturing Co
PB-104B-CORD5
In Commercial Distribution

  • 00645724004035 ()
PB104BCORD5

  • Physical therapy paraffin wax bath
PB104-PARAFFIN BATH 220V ISRAEL CORD
Whitehall Manufacturing Co
PB-104B-CORD4
In Commercial Distribution

  • 00645724004028 ()
PB104BCORD4

  • Physical therapy paraffin wax bath
PB104-PARAFFIN BATH 220V AUSTRALIAN CORD
Whitehall Manufacturing Co
PB-104B-CORD3
In Commercial Distribution

  • 00645724004011 ()
PB104CORDB

  • Physical therapy paraffin wax bath
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