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 packages per box
KEY SURGICAL, INC.
SL101
In Commercial Distribution

  • 20849771052764 ()
  • 10849771052767 ()
  • 00849771052760 ()
  • 00849771033332 ()
SL101

  • Procedural medication labelling set
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
KIT 45805 FP STRATA 2 ADJUSTMENT
MEDTRONIC PS MEDICAL, INC.
45805
In Commercial Distribution

  • 00643169990883 ()


  • Cerebrospinal fluid shunt valve programmer
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
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
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
SET ADJUST 45905 STRATAMR MAGNET
MEDTRONIC PS MEDICAL, INC.
45905
In Commercial Distribution

  • 00643169692886 ()


  • Cerebrospinal fluid shunt valve programmer
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-2
In Commercial Distribution

  • 06430065790013 ()


  • 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
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
No Description
AVID MEDICAL, INC.
BILX013-02_0006
In Commercial Distribution

  • 20809160224288 ()
  • 10809160224281 ()
BILX013-02

  • Ophthalmic crosslinking ultraviolet phototherapy system
No Description
SOPHYSA
PAK3-ERI
In Commercial Distribution

  • 03760124132199 ()


  • Cerebrospinal fluid shunt valve programmer
POLARIS SETTING INSTRUMENT-3
SOPHYSA
PAK3-SI
Not in Commercial Distribution

  • 03760124132144 ()


  • Cerebrospinal fluid shunt valve programmer
POLARIS READING INSTRUMENT-3
SOPHYSA
PAK3-RI
Not in Commercial Distribution

  • 03760124132137 ()


  • Cerebrospinal fluid shunt valve programmer
POLARIS LOCATING INSTRUMENT-3
SOPHYSA
PAK3-LI
Not in Commercial Distribution

  • 03760124132120 ()


  • Cerebrospinal fluid shunt valve programmer
POLARIS VALVE ADJUSTMENT KIT -3
SOPHYSA
PAK3
Not in Commercial Distribution

  • 03760124132113 ()


  • Cerebrospinal fluid shunt valve programmer
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