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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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Zimmer GmbH
01.00561.224
In Commercial Distribution

  • 00889024480773 ()

  • 24
01.00561.224

  • Revision uncoated hip femur prosthesis
Lexie Lumen self-fitting Silver hearing aid - Duo
HEARX GROUP (PTY) LTD
Lumen Duo Silver
In Commercial Distribution

  • 10850022464000 ()
  • 00850022464003 ()
Lumen 155

  • Air-conduction hearing aid, behind-the-ear
Lexie Lumen self-fitting Beige hearing aid - Duo
HEARX GROUP (PTY) LTD
Lumen Duo Beige
In Commercial Distribution

  • 10860003469801 ()
  • 00860003469804 ()
Lumen 155

  • Air-conduction hearing aid, behind-the-ear
Nova Max 10 Glucose Test Strips
NOVA BIOMEDICAL CORPORATION
Plus
In Commercial Distribution

  • 10385480436042 ()
  • 00385480436045 ()
43604

  • Glucose monitoring system IVD, home-use
The membrane and the electrolyte of SenTec TC Sensors must be changed periodically. For this purpose the old sensor membrane must be removed, the sensor surface must be cleaned, new electrolyte must be applied and a new sensor membrane must be put on. The patented Membrane Changer (MC) is a tool that allows the user to carry out the whole membrane change process by 4 simple press-and-turn steps. The MC is single-use.
SenTec AG
MC
In Commercial Distribution

  • 07640121880933 ()
  • 17640121880930 ()


  • Transcutaneous blood gas monitoring system
  • Transcutaneous blood gas monitor sensor
  • Pulse Co-oximeter probe, reusable
0 Mono 30x30
Surgical Specialties México, S. de R.L. de C.V.
YA-1051Q
In Commercial Distribution

  • 10848782022035 ()
  • 00848782022038 ()

  • 0 USP


  • Barbed polyester suture, non-antimicrobial
"UNITED" USTAR II Knee System
UNITED ORTHOPEDIC CORP.
2215-1400
In Commercial Distribution

  • 04711605580052 ()
2215-1400

  • Rotating hinged total knee prosthesis
THC CONTROL 0
UTAK LABORATORIES, INC.
THC QC 0 U F WDH
In Commercial Distribution

  • B800THCQC0UFWDH5 ()
  • B800THCQC0UFWDH0 ()

  • Total Volume: 10 Milliliter
THC QC 0 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
THC LEVEL 0
UTAK LABORATORIES, INC.
THC 0 U F WDH
In Commercial Distribution

  • B800THC0UFWDH5 ()
  • B800THC0UFWDH0 ()

  • Total Volume: 10 Milliliter
THC 0 U F WDH

  • Multiple-type clinical chemistry analyte profile IVD, control
The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is avaible in a variety of sizes and two angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844015728 ()

  • 12x9x29mm
B20120929

  • Polymeric spinal interbody fusion cage
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