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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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Camouflage Universal Enamel, Shade A1, 4g Syringe
Prismatik Dentalcraft, Inc
70-1151-CMU0005
Not in Commercial Distribution

  • D745701151CMU00050 ()

  • Weight: 4 Gram
70-1151-CMU0005

  • Dental composite resin
Camouflage Universal Enamel, Bleach, 4g Syringe
Prismatik Dentalcraft, Inc
70-1151-CMU0004
In Commercial Distribution

  • D745701151CMU00040 ()

  • Weight: 4 Gram
70-1151-CMU0004

  • Dental composite resin
Camouflage Universal Dentin, Shade A3, 4g Syringe
Prismatik Dentalcraft, Inc
70-1151-CMU0002
In Commercial Distribution

  • D745701151CMU00020 ()

  • Weight: 4 Gram
70-1151-CMU0002

  • Dental composite resin
Thyreoglobulin - IMMULITE - CONS - 3x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385247
In Commercial Distribution

  • 00630414978345 ()
LTYCM(D)

  • Thyroglobulin IVD, control
Thyreoglobulin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381647
In Commercial Distribution

  • 00630414972084 ()
L2KTY2(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
DTS Guide
Pioneer Surgical Technology, Inc.
66-DTS-GUIDE-24
Not in Commercial Distribution

  • 00846468088040 ()

  • 24°
66-DTS-GUIDE-24

  • Orthopaedic implantation sleeve, reusable
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
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
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
Nova Max 10 Glucose Test Strips
NOVA BIOMEDICAL CORPORATION
Plus
In Commercial Distribution

  • 10385480436042 ()
  • 00385480436045 ()
43604

  • Glucose monitoring system IVD, home-use
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