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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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RPI
LKM002
In Commercial Distribution

  • 00841034113546 ()
LKM002

  • Electrocardiographic lead set, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287361244
In Commercial Distribution

  • 09421028118491 ()
287361244

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287361243
In Commercial Distribution

  • 09421028118484 ()
287361243

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287361242
In Commercial Distribution

  • 09421028118415 ()
287361242

  • Orthopaedic inorganic implant inserter/extractor, reusable
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
ENZTEC LIMITED
287361241
In Commercial Distribution

  • 09421028118408 ()
287361241

  • Orthopaedic inorganic implant inserter/extractor, reusable
This is a medical device.
KaVo Dental GmbH
1.006.1957
In Commercial Distribution

  • EKAV100619570 ()
rootplaner Tip No 24 A

  • Ultrasonic dental scaling/debridement system
For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered within an outpatient or inpatient clinical setting by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.
Nuwellis Inc.
210104
In Commercial Distribution

  • 30853072007306 ()
  • 10853072007289 ()
210104

  • Haemofilter
Application for sending a live video stream from the medical operating theater to remote viewers. The class of HW devices with or without a touch panel display (TPD). It is used to connect to a video source and capture, archive and stream the video to the Orpheus System central server and over the multi-cast network to be viewed from the Orpheus Show application.
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025025 ()

  • Depth: 21 Centimeter
  • Height: 60 Centimeter
  • Width: 74 Centimeter
  • Weight: 13.2 Kilogram
MCU-EG00402

  • Electrosurgical system monitor/shield
Ext. Hex Reduced Platform Implant, 24° Co-Axis™, Ø4.0 x 8.5mm
SOUTHERN IMPLANTS (PTY) LTD
IBR24D-8.5
In Commercial Distribution

  • 06009544024521 ()


  • Screw endosteal dental implant, two-piece
Ext. Hex Reduced Platform Implant, 24° Co-Axis™, Ø4.0 x 24mm
SOUTHERN IMPLANTS (PTY) LTD
IBR24D-24
In Commercial Distribution

  • 06009544024514 ()


  • Screw endosteal dental implant, two-piece
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