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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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G-EYE Colonoscope - 07290018671245

The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning within the lumen and help control the endoscope’s view field and/or endoscope positioning.
SMART MEDICAL SYSTEMS LTD
G-EYEH190I
In Commercial Distribution

  • 07290018671245 ()
40-560

  • Flexible fibreoptic colonoscope

G-EYE Colonoscope - 07290018671238

The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning within the lumen and help control the endoscope’s view field and/or endoscope positioning.
SMART MEDICAL SYSTEMS LTD
G-EYEH190L
In Commercial Distribution

  • 07290018671238 ()
40-560

  • Flexible fibreoptic colonoscope

G-EYE Colonoscope - 07290018671221

The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning within the lumen and help control the endoscope’s view field and/or endoscope positioning.
SMART MEDICAL SYSTEMS LTD
G-EYEHQ190I
In Commercial Distribution

  • 07290018671221 ()
40-560

  • Flexible fibreoptic colonoscope

G-EYE Colonoscope - 07290018671214

The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning within the lumen and help control the endoscope’s view field and/or endoscope positioning.
SMART MEDICAL SYSTEMS LTD
G-EYEHQ190L
In Commercial Distribution

  • 07290018671214 ()
40-560

  • Flexible fibreoptic colonoscope

G-EYE Colonoscope - 07290018671153

The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning within the lumen and help control the endoscope’s view field and/or endoscope positioning.
SMART MEDICAL SYSTEMS LTD
G-EYE38-i10L
In Commercial Distribution

  • 07290018671153 ()
40-538

  • Flexible fibreoptic colonoscope

smartheart - 07290008960359

The smartheart is a personal, hand-held battery powered, 12 lead EG and rhythm strip device with Bluetooth connection. The smartheart acquires EGG data via attached electrodes. The smartheart transmits the data in real-time to a suitable Bluetooth communication device for forwarding it to a remote location and a certified medical professional capable of interpreting the results.
SHL TELEMEDICINE INTERNATIONAL LTD.
3.3
In Commercial Distribution

  • 07290008960359 ()

  • belt/ 32 cm
  • Height: 1.5 Centimeter
  • Width: 8.5 Centimeter
  • Length: 11 Centimeter
  • Weight: 110 Gram


  • Electrocardiograph, home-use

RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER - 07290008960267

The Cardio'R is an event recorder that helps physician's document heart problems, which may not be found during a routine ECG examination in a healthcare facility. The device stores the ECG data and transmits it either automatically or manually to a receiving center, which can be a physician's office, hospital or medical center. The receiving center is staffed by healthcare professionals and contains advanced software to convert the data and interpret the results.
SHL TELEMEDICINE INTERNATIONAL LTD.
E-560-0 / E-561-0
In Commercial Distribution

  • 07290008960267 ()

  • Length: 90 Millimeter
  • Width: 75 Millimeter
  • Depth: 30 Millimeter
  • Weight: 200 Gram


  • Electrocardiograph, home-use

FUJIFILM - 24547410095580

This product is intended to inject air, water or reprocessing fluids to the air/water channel during manual cleaning of a FUJIFILM endoscope in medical facilities. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CA-500N
In Commercial Distribution

  • 34547410095587 ()
  • 24547410095580 ()


  • Endoscope flushing adaptor, reusable

InModeRF hand piece - 07290019863076

Fractional RF Quantum Handpiece which comprises canula with active electrodes, handle, cable and connector Handpiece HP2539B6A has a canula of 3.3mm diameter and 25cm long. Maximal RF power is 60W.
INMODE M.D LTD
HP2539B6A
In Commercial Distribution

  • 07290019863076 ()
HP2539B6A

  • Radio-frequency fat liquefaction system

InModeRF hand piece - 07290019863069

Fractional RF Quantum Handpiece which comprises canula with active electrodes, handle, cable and connector Handpiece HP1022B6A has a canula diameter of 2mm and 10cm long. Maximal RF power is 35W.
INMODE M.D LTD
HP1022B6A
In Commercial Distribution

  • 07290019863069 ()
HP1022B6A

  • Radio-frequency fat liquefaction system

InMode RF hand piece - 07290019863045

Handpiece comprises internal active electrode, external return electrode, both with temperature sensor, handle, cable and connector. Handpiece HP102206 has an active electrode diameter of 2mm and return electrode of 13.5mm diameter and 10cm long. Maximal RF power 20W.
INMODE M.D LTD
HP102206A
Not in Commercial Distribution

  • 07290019863045 ()
HP102206A

  • Radio-frequency fat liquefaction system

Hetaida - 06970289035861

Behind-the-Ear Hearing Aid
Hetaida Technology Co., Ltd
HTD6101US
In Commercial Distribution

  • 16970289035868 ()
  • 06970289035861 ()


  • Air-conduction hearing aid, receiver-in-the-ear

NA - 06970289035717

Non-Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8808C
In Commercial Distribution

  • 16970289035714 ()
  • 06970289035717 ()


  • Infrared patient thermometer, skin

Hetaida - 06970289035694

Electric Nasal Aspirator
Hetaida Technology Co., Ltd
H2605US
In Commercial Distribution

  • 16970289035691 ()
  • 06970289035694 ()


  • Nasal aspirator, electric

hetaida - 06970289035670

Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8819C
In Commercial Distribution

  • 16970289035677 ()
  • 06970289035670 ()


  • Infrared patient thermometer, skin

Optimal - 06970289035663

Infrared Body Thermometer
Hetaida Technology Co., Ltd
H8228US
In Commercial Distribution

  • 16970289035660 ()
  • 06970289035663 ()


  • Infrared patient thermometer, skin

femometer family - 06970289035625

Infrared Body Thermometer
Hetaida Technology Co., Ltd
K8832US
In Commercial Distribution

  • 16970289035622 ()
  • 06970289035625 ()


  • Infrared patient thermometer, skin

Hetaida - 06970289035595

Non-Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8816C
In Commercial Distribution

  • 16970289035592 ()
  • 06970289035595 ()


  • Infrared patient thermometer, skin

Hetaida - 06970289035557

No Description
Hetaida Technology Co., Ltd
HTD8208C
In Commercial Distribution

  • 16970289035554 ()
  • 06970289035557 ()

  • Height: 45 Millimeter
  • Width: 36 Millimeter
  • Length: 160 Millimeter


  • Infrared patient thermometer, skin

joyhicare - 06970289035526

Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
H8830US
In Commercial Distribution

  • 16970289035523 ()
  • 06970289035526 ()


  • Infrared patient thermometer, skin

YOOKO - 06970289035519

Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8823US
In Commercial Distribution

  • 16970289035516 ()
  • 06970289035519 ()


  • Infrared patient thermometer, skin

Hetaida - 06970289035502

Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8813C
In Commercial Distribution

  • 16970289035509 ()
  • 06970289035502 ()


  • Infrared patient thermometer, skin

Hetaida - 06970289035496

Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8813C
In Commercial Distribution

  • 16970289035493 ()
  • 06970289035496 ()


  • Infrared patient thermometer, skin

YOOKO - 06970289035489

Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8216C
In Commercial Distribution

  • 16970289035486 ()
  • 06970289035489 ()

  • Height: 52 Centimeter
  • Width: 34 Centimeter
  • Length: 154 Centimeter


  • Infrared patient thermometer, skin

Joyhicare - 06970289035472

BTE Hearing Aid
Hetaida Technology Co., Ltd
HTD6101US
In Commercial Distribution

  • 16970289035479 ()
  • 06970289035472 ()


  • Air-conduction hearing aid, receiver-in-the-ear

Hetaida - 06970289035465

Infrared Body Thermometer
Hetaida Technology Co., Ltd
H8228US
In Commercial Distribution

  • 16970289035462 ()
  • 06970289035465 ()

  • Height: 52 Centimeter
  • Width: 34 Centimeter
  • Length: 154 Centimeter


  • Infrared patient thermometer, skin

DANZ - 06970289035458

Infrared Body Thermometer
Hetaida Technology Co., Ltd
H8228US
In Commercial Distribution

  • 16970289035455 ()
  • 06970289035458 ()

  • Height: 52 Centimeter
  • Width: 34 Centimeter
  • Length: 154 Centimeter


  • Infrared patient thermometer, skin

Hetaida - 06970289035441

Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8816C
In Commercial Distribution

  • 16970289035448 ()
  • 06970289035441 ()


  • Infrared patient thermometer, skin

Joyhicare - 06970289035434

Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8222US
In Commercial Distribution

  • 16970289035431 ()
  • 06970289035434 ()


  • Infrared patient thermometer, skin

Joyhicare - 06970289035427

Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8816C
In Commercial Distribution

  • 16970289035424 ()
  • 06970289035427 ()


  • Infrared patient thermometer, skin

Hetaida - 06970289035410

Electric Nasal Aspirator
Hetaida Technology Co., Ltd
HTD2601US
In Commercial Distribution

  • 16970289035417 ()
  • 06970289035410 ()


  • Nasal aspirator, electric

eClear - 06970289035403

Electric Nasal Aspirator
Hetaida Technology Co., Ltd
HTD2601US
In Commercial Distribution

  • 16970289035400 ()
  • 06970289035403 ()


  • Nasal aspirator, electric

joyhicare - 06970289035397

Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
H8830US
In Commercial Distribution

  • 16970289035394 ()
  • 06970289035397 ()


  • Infrared patient thermometer, skin

Hetaida - 06970289035380

BTE Hearing Aid
Hetaida Technology Co., Ltd
HTD6101US
In Commercial Distribution

  • 16970289035387 ()
  • 06970289035380 ()


  • Air-conduction hearing aid, receiver-in-the-ear

joyhicare - 06970289035373

Electric Nasal Aspirator
Hetaida Technology Co., Ltd
HTD2602US
In Commercial Distribution

  • 16970289035370 ()
  • 06970289035373 ()


  • Nasal aspirator, electric

YOOKO - 06970289035366

Electric Nasal Aspirator
Hetaida Technology Co., Ltd
HTD2601US
In Commercial Distribution

  • 16970289035363 ()
  • 06970289035366 ()


  • Nasal aspirator, electric

Hetaida - 06970289035359

Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8219US
In Commercial Distribution

  • 16970289035356 ()
  • 06970289035359 ()


  • Infrared patient thermometer, skin

Hetaida - 06970289035342

Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8222US
In Commercial Distribution

  • 16970289035349 ()
  • 06970289035342 ()


  • Infrared patient thermometer, skin

Hetaida - 06970289035335

Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8808C
In Commercial Distribution

  • 16970289035332 ()
  • 06970289035335 ()


  • Infrared patient thermometer, skin

Hetaida - 06970289035328

Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8813C
In Commercial Distribution

  • 16970289035325 ()
  • 06970289035328 ()


  • Infrared patient thermometer, skin
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