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 - General Liquids, 10 labels per panel, 1 panel per pouch, 100 packages per box
KEY SURGICAL, INC.
SL100
In Commercial Distribution

  • 50849771050662 ()
  • 10849771050664 ()
  • 00849771050667 ()
  • 00849771033172 ()
SL100

  • Procedural medication labelling set
Sterile Labels - Custom CAME017, 10 labels per panel, 1 panel per pouch, 100 packages per box
KEY SURGICAL, INC.
SL118
In Commercial Distribution

  • 20849771039994 ()
  • 10849771039997 ()
  • 00849771039990 ()
SL118

  • Procedural medication labelling set
12 Panel Preview Panel,AMP,BAR,BUP,BZO,COC,mAMP,MDMA,MTD,OPI,OXY,PCP,THC
WONDFO USA CO., LTD.
PRE-WDOA-6124
In Commercial Distribution

  • 00816862021707 ()
  • 00816862021691 ()
  • 10816862021704 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
LabPro V5.0 Panel Update 10 (US), Electronic - C90679; DVD, LabPro V5.0 Panel Update 10 (US) - C90680
Beckman Coulter, Inc.
V5.00
In Commercial Distribution

  • 15099590772741 ()
  • 15099590772758 ()
C90679, C90680

  • Microorganism identification/antimicrobial-susceptibility analyser IVD
No Description
SIZEWISE RENTALS, L.L.C.
BDRIVE
In Commercial Distribution

  • 00845699001989 ()


  • Bed transporter
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
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
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
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

  • 00643169990883 ()


  • 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
SET ADJUST 45905 STRATAMR MAGNET
MEDTRONIC PS MEDICAL, INC.
45905
In Commercial Distribution

  • 00643169692886 ()


  • Cerebrospinal fluid shunt valve programmer
Ultrasound imaging system main unit
Cortex Technology ApS
08
In Commercial Distribution

  • 05710188039000 ()
A0390008

  • Ultrasound imaging system operator console
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
No Description
Bone Index Finland Oy
BI-100
Not in Commercial Distribution

  • 06430065790006 ()


  • 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.
BILX013-02_0006
In Commercial Distribution

  • 20809160224288 ()
  • 10809160224281 ()
BILX013-02

  • Ophthalmic crosslinking ultraviolet phototherapy system
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