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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Sterile Labels - Custom, 10 labels per panel, 1 panel per pouch, 100 pouches per Box
KEY SURGICAL, INC.
Sterile Labels
In Commercial Distribution

  • 20849771050357 ()
  • 10849771050350 ()
  • 00849771032137 ()
  • 00849771050353 ()
SL106

  • Procedural medication labelling set
Gamma Camera Workstation for Acquisition, Reviewing and Processing
MiE medical imaging electronics GmbH
SCINTRON
In Commercial Distribution

  • 04260484140050 ()


  • Nuclear medicine system operator console, multi-purpose
Nuclear Medicine Workstation for Aquisition, Viewing and Processing
MiE medical imaging electronics GmbH
ECAT Scintron PET
In Commercial Distribution

  • 04260484140029 ()


  • Nuclear medicine system operator console, multi-purpose
SET ADJUST 45905 STRATAMR MAGNET
MEDTRONIC PS MEDICAL, INC.
45905
In Commercial Distribution

  • 00643169692886 ()


  • Cerebrospinal fluid shunt valve programmer
KIT 45805 FP STRATA 2 ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
45805
In Commercial Distribution

  • 00643169990883 ()


  • Cerebrospinal fluid shunt valve programmer
No Description
SIZEWISE RENTALS, L.L.C.
BDRIVE
In Commercial Distribution

  • 00845699001989 ()


  • Bed transporter
TOOL 27826 STRATA II ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
27826
In Commercial Distribution

  • 00643169498068 ()


  • Cerebrospinal fluid shunt valve programmer
KIT 45805 FP STRATA 2 ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
45805
In Commercial Distribution

  • 00643169497634 ()


  • Cerebrospinal fluid shunt valve programmer
KIT 45806 STRATA VARIUS
MEDTRONIC PS MEDICAL, INC.
45806
In Commercial Distribution

  • 00643169497627 ()


  • Cerebrospinal fluid shunt valve programmer
TOOL 45809 STRATAVARIUS ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
45809
In Commercial Distribution

  • 00643169497610 ()


  • Cerebrospinal fluid shunt valve programmer
KIT 45806 STRATA VARIUS
MEDTRONIC PS MEDICAL, INC.
45806
In Commercial Distribution

  • 00643169373686 ()


  • Cerebrospinal fluid shunt valve programmer
RAF BINOCULAR GAUGE
HAAG-STREIT UK LIMITED
7006001
In Commercial Distribution

  • 05060179470375 ()
7006001

  • Ophthalmic binocular gauge
KIT 45806 STRATA VARIUS
MEDTRONIC PS MEDICAL, INC.
45806
In Commercial Distribution

  • 00643169980402 ()


  • Cerebrospinal fluid shunt valve programmer
KIT 45805 FP STRATA 2 ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
45805
In Commercial Distribution

  • 00643169975903 ()


  • Cerebrospinal fluid shunt valve programmer
No Description
Bone Index Finland Oy
BI-2
In Commercial Distribution

  • 06430065790013 ()


  • Bone absorptiometric ultrasound system
Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41.
Bone Index Finland Oy
v4 (w/o Gel)
In Commercial Distribution

  • 06430065790068 ()


  • Bone absorptiometric ultrasound system
Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41.
Bone Index Finland Oy
v3 (w/o Gel)
In Commercial Distribution

  • 06430065790051 ()


  • Bone absorptiometric ultrasound system
Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41.
Bone Index Finland Oy
v2 (w/o Gel)
In Commercial Distribution

  • 06430065790044 ()


  • Bone absorptiometric ultrasound system
Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41. Compartment for gel bottle included.
Bone Index Finland Oy
v1 (w/ Gel)
In Commercial Distribution

  • 06430065790037 ()


  • Bone absorptiometric ultrasound system
Measuring stick for defining the standard location for Bindex measurement.
Bone Index Finland Oy
BI-41
In Commercial Distribution

  • 06430065790020 ()


  • Bone absorptiometric ultrasound system
No Description
Bone Index Finland Oy
BI-100
Not in Commercial Distribution

  • 06430065790006 ()


  • Bone absorptiometric ultrasound system
No Description
AVEDRO, INC.
110-02724
In Commercial Distribution

  • 00855574003083 ()


  • Ophthalmic crosslinking ultraviolet phototherapy system
No Description
AVEDRO, INC.
110-02723
In Commercial Distribution

  • 00855574003007 ()


  • Ophthalmic crosslinking ultraviolet phototherapy system
Ultrasound imaging system main unit
Cortex Technology ApS
08
In Commercial Distribution

  • 05710188039000 ()
A0390008

  • Ultrasound imaging system operator console
CODMAN HAKIM Valve Programmer, 100-240V
Cerenovus, Inc.
82-3190
Not in Commercial Distribution

  • 10886704041597 ()
823190

  • Cerebrospinal fluid shunt valve programmer
CODMAN CERTAS Plus Electronic Tool Kit
Cerenovus, Inc.
82-8852
Not in Commercial Distribution

  • 10886704081272 ()
828852

  • Cerebrospinal fluid shunt valve programmer
CODMAN CERTAS REPLACEMENT TOOL, ADJUSTABLE HEIGHT LOCATOR for use ONLY as part of the CODMAN CERTAS TOOL KIT (REF: 82-8851)
Medos International Sàrl
82-8861
Not in Commercial Distribution

  • 10886704079132 ()
828861

  • Cerebrospinal fluid shunt valve programmer
CODMAN CERTAS REPLACEMENT TOOL, INDICATOR for use ONLY as part of the CODMAN CERTAS TOOL KIT (REF: 82-8851)
Medos International Sàrl
82-8860
Not in Commercial Distribution

  • 10886704079125 ()
828860

  • Cerebrospinal fluid shunt valve programmer
CODMAN HAKIM Valve Programmer, 100-240V, IEC NOTICE: Do not exceed the following transport and storage conditions. Temperature -40 DEGREES C - +60 DEGREES C Relative Humidity 10 Percent - 85 Percent Atmospheric Pressure 500hPa - 1060hPa
Cerenovus, Inc.
823190R
Not in Commercial Distribution

  • 10886704078616 ()
823190R

  • Cerebrospinal fluid shunt valve programmer
CODMAN VPV System Contents: One Each: CODMAN VPV Program Unit, CODMAN VPV Transmitter Unit, Power Cord, Ultrasound Gel, Instructions for Use, and Carrying Case
Cerenovus, Inc.
823192R
Not in Commercial Distribution

  • 10886704078609 ()
823192R

  • Cerebrospinal fluid shunt valve programmer
CODMAN CERTAS Tool Kit
Medos International Sàrl
82-8851
Not in Commercial Distribution

  • 10886704074793 ()
828851

  • Cerebrospinal fluid shunt valve programmer
CODMAN CERTAS Therapy Management System
Medos International Sàrl
82-8850D
Not in Commercial Distribution

  • 10886704071419 ()
828850D

  • Cerebrospinal fluid shunt valve programmer
CODMAN CERTAS Therapy Management System
Medos International Sàrl
82-8850
Not in Commercial Distribution

  • 10886704071402 ()
828850

  • Cerebrospinal fluid shunt valve programmer
BONE ULTRASONOMETER, ACHILLES
GE Medical Systems (China) Co.,Ltd.
v1
Not in Commercial Distribution

  • 00840682116978 ()


  • Bone absorptiometric ultrasound system
Source Loading Adapter
Nucletron B.V.
080287P01-00
In Commercial Distribution

  • 08717213006836 ()
  • 08717213041455 ()


  • Brachytherapy system remote-afterloading operator console
No Description
ECHOLIGHT SPA
EchoStation
In Commercial Distribution

  • 08052461860015 ()


  • Bone absorptiometric ultrasound system
No Description
ECHOLIGHT SPA
EchoS
In Commercial Distribution

  • 08052461860008 ()


  • Bone absorptiometric ultrasound system
No Description
AVID MEDICAL, INC.
BILX013-02_0006
In Commercial Distribution

  • 20809160224288 ()
  • 10809160224281 ()
BILX013-02

  • Ophthalmic crosslinking ultraviolet phototherapy system
No Description
AVID MEDICAL, INC.
VARV027-17_0001
In Commercial Distribution

  • 20809160209988 ()
  • 10809160209981 ()
VARV027-17

  • Ophthalmic crosslinking ultraviolet phototherapy system
No Description
AVID MEDICAL, INC.
VAML043-02_0002
In Commercial Distribution

  • 20809160209414 ()
  • 10809160209417 ()
VAML043-02

  • Ophthalmic crosslinking ultraviolet phototherapy system
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