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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No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-0920
In Commercial Distribution

  • 09348215125431 ()


  • Medullary canal orthopaedic reamer, flexible
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-0910
In Commercial Distribution

  • 09348215125424 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-0930
In Commercial Distribution

  • 09348215125417 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
The PREVI Color Gram is an in vitro diagnostic medical device for professional use. It has been designed to gram stain specimen smears on microscope slides.
BIOMERIEUX SA
414292
In Commercial Distribution

  • 03573026415310 ()


  • Microscope slide stainer IVD
For the collection of the first catch male urine specimen. For in vitro diagnostic use.
Diagnostics For The Real World Limited
2.0
In Commercial Distribution

  • B714C060005 ()
  • B714C060005850 ()
C06-0005-85

  • Non-evacuated urine specimen container IVD, no additive
No Description
Orthosoft Inc
20-8000-070-77
Not in Commercial Distribution

  • 00889024478978 ()
20-8000-070-77

  • Robotic surgical navigation system
Kit SST-F for the retrofitting of 10 shelves freezer
BIOLOG-ID
01
In Commercial Distribution

  • B765PRD7140300 ()


  • Blood refrigerator/freezer
No Description
UTAK LABORATORIES, INC.
P/Z QC V2 L U F ML
In Commercial Distribution

  • B80002942500101 ()
  • B80002942500100 ()
  • B80002942500102 ()
  • B80002942500103 ()
  • B80002942500106 ()
  • B80002942500107 ()
  • B80002942500108 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
VERAN MEDICAL TECHNOLOGIES INC.
SYS-2230
Not in Commercial Distribution

  • 00815686020071 ()
SYS-2230

  • Electromagnetic surgical navigation device tracking system
No Description
VERAN MEDICAL TECHNOLOGIES INC.
SYS-2000
Not in Commercial Distribution

  • 00815686020064 ()
SYS-2000

  • Electromagnetic surgical navigation device tracking system
No Description
GLOBAL SURGICAL CORPORATION
M A730-HAV2
In Commercial Distribution

  • 00810040255434 ()


  • General-purpose surgical microscope
No Description
GLOBAL SURGICAL CORPORATION
M A801-LEDV2
In Commercial Distribution

  • 00810040255403 ()


  • General-purpose surgical microscope
No Description
GLOBAL SURGICAL CORPORATION
M A517HD1080V2
In Commercial Distribution

  • 00810040255113 ()


  • General-purpose surgical microscope
Ø5.5mm x 200mm Rod Template
SPINEOLOGY INC.
10-46-29
In Commercial Distribution

  • M7409000015 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 400 Millimeter
900-0015

  • Internal spinal fixation procedure kit, reusable
Demo De Mayo V2® Knee Positioner® (30" Baseplate w/carriage,803-ABD, 114-CL Clamp)
Innovative Medical Products, Inc
114 KIT DEMO
In Commercial Distribution

  • 00696588005355 ()
114 KIT DEMO

  • Leg procedure positioner
Loaner De Mayo V2® Knee Positioner® (25" Baseplate w/carriage,803-ABD, 114-CL Clamp)
Innovative Medical Products, Inc
114-S LOANER
In Commercial Distribution

  • 00696588004471 ()
114-S LOANER

  • Leg procedure positioner
Loaner De Mayo V2® Knee Positioner® (30" Baseplate w/carriage,803-ABD, 114-CL Clamp)
Innovative Medical Products, Inc
114-LOANER
In Commercial Distribution

  • 00696588004464 ()
114-LOANER

  • Leg procedure positioner
The HarmonyAIR A-Series Handle, Non Sterilzable V2 is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
LAS0042
In Commercial Distribution

  • 00724995217372 ()
LAS0042

  • Medical equipment handle cover, reusable
DURAY V2, MOBILE DC Intraoral X-Ray, 60kV & 70kV, 100-230V, 50/60 Hz, 80cm arm length
Beyes Dental Canada Inc
XR2012
In Commercial Distribution

  • 00837699000093 ()


  • Stationary intraoral dental x-ray system, digital
Connex Cardio WAM ECG acquisition module v2, without lead wires, for use with Connex Cardio
WELCH ALLYN, INC.
901095
In Commercial Distribution

  • 00817655023090 ()
30012-019-76

  • Electrocardiograph, professional, multichannel
Custom 500 EVA 2-Bag set with spikes, 55-100ml, "V2" Tube Set, 2 sets per pouch
ORIGEN BIOMEDICAL, INC.
CS500V2
In Commercial Distribution

  • 20816203021247 ()
  • 10816203021240 ()
  • 00816203021243 ()
CS500V2

  • Blood/tissue storage/culture container
De Mayo V2® Knee Positioner® (25" w/803-ABD, 114-CL, 180° Flip Handle Assembly & 803-GP-10)
Innovative Medical Products, Inc
114-S KIT-P
In Commercial Distribution

  • 00696588006970 ()
114-S KIT-P

  • Leg procedure positioner
De Mayo V2® Knee Positioner® (30" w/803-ABD, 114-CL, 180° Flip Handle Assembly & 803-GP-10)
Innovative Medical Products, Inc
114 KIT-P
In Commercial Distribution

  • 00696588006406 ()
114 KIT-P

  • Leg procedure positioner
De Mayo V2® Knee Positioner® for Lab use only (30" Base and Boot only)
Innovative Medical Products, Inc
114-LAB
In Commercial Distribution

  • 00696588005423 ()
114-LAB

  • Leg procedure positioner
Portable Stretcher
T.S.G. ASSOCIATES LLP
XtractSR Afloat V2
In Commercial Distribution

  • 05060766500102 ()


  • Portable stretcher
No Description
BONRAYBIO CO., LTD.
QXB V2 package
In Commercial Distribution

  • 04719874741051 ()
X QC Video

  • Sperm concentration indicator IVD, control
Indications for use: 8 channel EMG Amplifier 1. To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric. 2. To clinically monitor up to eight different muscles as an aid in the diagnosis and treatments evaluation by recording the electrical activity of muscles of the stomatognathic system. 3. To determine the degree of relaxation (intra-patient) of a single muscle/group of muscles at rest. 4. To measure relative (intra-patient) levels of activity of several muscles during a functional act. Indications for use: 2 channel JVA amplifier 1. To record and display sounds/vibrations from the temporomandibular joints. 2. To aid the clinician in their analysis of a joint sound/vibration by allowing them to see the waveform in various standard plots. 3. To aid the clinician in comparing a patient's current stand plots to previous recordings before, during, and after treatment. 4. To provide numerical values that can be used to quantify the physical characteristics of the sounds/vibrations, allowing intra-patient comparisons (only) by the clinician.
Bio-Research Associates, Inc.
III NRG V2
In Commercial Distribution

  • 00860003499900 ()


  • Jaw physiology evaluation system
No Description
U&C International Co.,Ltd
Effect V2 40ml
In Commercial Distribution

  • 08800118623144 ()


  • Dental appliance fabrication material, ceramic
Evaluation De Mayo V2™ Knee Positioner® 30" Baseplate w/Removable Carriage & Single Bar Lock Base
Innovative Medical Products, Inc
114-BP EVAL
In Commercial Distribution

  • 00696588005379 ()
114-BP EVAL

  • Leg procedure positioner
De Mayo V2® Knee Positioner® (30" w/803-ABD, 114-CL, 180° Flip Handle Assembly, 907 & 907-GP-10)
Innovative Medical Products, Inc
114-907 Kit-P
In Commercial Distribution

  • 00696588006451 ()
114-907 Kit-P

  • Leg procedure positioner
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