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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11cen in Aqua Spectrum v2
CYTOCELL LIMITED
MPD20993
In Commercial Distribution

  • 05055844909205 ()


  • Assay development analyte-specific reagent IVD
11q23 in FITC Spectrum v2
CYTOCELL LIMITED
MPD20992
In Commercial Distribution

  • 05055844909199 ()


  • Assay development analyte-specific reagent IVD
RETRACTOR HOLDER 9734119 HEADHOLDER V2
MEDTRONIC NAVIGATION, INC.
9734119
In Commercial Distribution

  • 00613994575463 ()


  • Extremity MRI system, permanent magnet
v2 Facemask- DP Dermaceuticals Branded
I-SMART DEVELOPMENTS LIMITED
TN19G
In Commercial Distribution

  • 05060534510104 ()
111B

  • Cosmetic red-light phototherapy system, home-use
MammoRx® Bottom Stop (V2)
Orfit Industries NV
CBS-2
In Commercial Distribution

  • 05420028709931 ()


  • Radiological whole-body positioner
MNA-420 DEC HDMI V2 IN
Barco NV
MNA-420
In Commercial Distribution

  • 05415334037625 ()
k9303331D

  • Operating room audiovisual data/device management system
NEXXIS SYSTEM X620 CM V2
Barco NV
Nexxis
In Commercial Distribution

  • 05415334030220 ()


  • Operating room audiovisual data/device management system
NEXXIS SYSTEM X670 CM V2
Barco NV
Nexxis
In Commercial Distribution

  • 05415334030213 ()


  • Operating room audiovisual data/device management system
MNA-420 DEC HDMI V2 UK
Barco NV
MNA-420 DEC
In Commercial Distribution

  • 05415334027329 ()
K9303331G

  • Operating room audiovisual data/device management system
MNA-240 DEC V2 INC SFP+
Barco NV
MNA-240 DEC
In Commercial Distribution

  • 05415334025011 ()
K9303275a

  • Operating room audiovisual data/device management system
ClearPoint v2.x Neuro Workstation
Clearpoint Neuro, Inc.
CP-WRK-03
In Commercial Distribution

  • 00850359007539 ()
CP-WRK-03

  • Neurological stereotactic surgery system
Somte PSG v2 lead kit
COMPUMEDICS LIMITED
Somte PSG v2
In Commercial Distribution

  • 09342451001474 ()
7023-0003-02

  • Electrical-only medical device connection cable, reusable
Grael v2 System, no software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001276 ()
9028-0001-02

  • Electroencephalograph
  • Polysomnograph
AIRTOUCH N30I SML STPK V2
RESMED PTY LTD
62309
In Commercial Distribution

  • 00619498623099 ()
62309

  • CPAP/BPAP nasal mask, reusable
AIRTOUCH N30I STD STPK V2
RESMED PTY LTD
62308
In Commercial Distribution

  • 00619498623082 ()
62308

  • CPAP/BPAP nasal mask, reusable
AIRFIT N30I SML STPK V2
RESMED PTY LTD
63839
In Commercial Distribution

  • 00619498638390 ()
63839

  • CPAP/BPAP nasal mask, reusable
AIRFIT N30I STD STPK V2
RESMED PTY LTD
63838
In Commercial Distribution

  • 00619498638383 ()
63838

  • CPAP/BPAP nasal mask, reusable
AMNIOTIC FLUID COLLECT KIT V2
MEDLINE INDUSTRIES, INC.
DYNJ59769A
In Commercial Distribution

  • 10193489500929 ()
  • 40193489500920 ()
DYNJ59769A

  • General surgical procedure kit, non-medicated, single-use
MAF v2 Probe Red (ASR)
CYTOCELL LIMITED
LPH567-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
Apnea Guard Device Medium (V2)
ADVANCED BRAIN MONITORING, INC.
25-1002
In Commercial Distribution

  • 00850015266010 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Apnea Guard Device Low (V2)
ADVANCED BRAIN MONITORING, INC.
25-1001
In Commercial Distribution

  • 00850015266003 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Apnea Guard Device High (V2)
ADVANCED BRAIN MONITORING, INC.
25-1003
In Commercial Distribution

  • 00850015266027 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
HEADGEAR CLIPS PKG V2 HEADGEAR
HANS RUDOLPH, INC.
7450
In Commercial Distribution

  • 00874750004010 ()
201555

  • Pulmonary function valve
ACC. ME IRIC CHARGER V2
Ws Audiology Usa, Inc.
MECHARGE iRIC Charger v2
In Commercial Distribution

  • 05714880161472 ()
21014782

  • Noninvasive device battery charger
UTK MODULE V2 ASSY - 2
WELCH ALLYN, INC.
901078
Not in Commercial Distribution

  • 00732094318388 ()
26025-092-404

  • Electrocardiograph, professional, multichannel
WADCS ECG SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315493 ()
729324

  • Electrocardiograph, professional, multichannel
WADCS SPIRO SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315486 ()
729325

  • Electrocardiograph, professional, multichannel
WADCS MANAGER SOFTWARE V2.X
WELCH ALLYN, INC.
901128
In Commercial Distribution

  • 00732094315479 ()
729326

  • Electrocardiograph, professional, multichannel
ELITE 2MHZ WATERPROOF PROBE V2
NATUS NEUROLOGY INCORPORATED
X1L008
In Commercial Distribution

  • 00382830028196 ()


  • Foetal Doppler system
Natus Elite v2 Software Update
NATUS NEUROLOGY INCORPORATED
688-630000
In Commercial Distribution

  • 00382830062268 ()


  • Electromyograph
Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630100
In Commercial Distribution

  • 00382830062244 ()


  • Electromyograph
Natus Elite v2 Reader Software
NATUS NEUROLOGY INCORPORATED
828-080000
In Commercial Distribution

  • 00382830062237 ()


  • Electromyograph
Natus Elite v2 Software - Viking
NATUS NEUROLOGY INCORPORATED
828-080200
In Commercial Distribution

  • 00382830062213 ()


  • Electromyograph
Natus Elite v2 Software - Synergy
NATUS NEUROLOGY INCORPORATED
828-080100
In Commercial Distribution

  • 00382830062206 ()


  • Electromyograph
AMNIOTIC FLUID COLLECT KIT V2
MEDLINE INDUSTRIES, INC.
DYNJ59769
In Commercial Distribution

  • 10888277782747 ()
DYNJ59769

  • General surgical procedure kit, non-medicated, single-use
CLOZAPINE 50 NG/ML V2
UTAK LABORATORIES, INC.
CLOZ 50 V2 UCI
In Commercial Distribution

  • B800CLOZ50V2UCI5 ()
  • B800CLOZ50V2UCI0 ()

  • Total Volume: 5 Milliliter
CLOZ 50 V2 UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
CLOZAPINE 250 NG/ML V2
UTAK LABORATORIES, INC.
CLOZ 250 V2 UCI
In Commercial Distribution

  • B800CLOZ250V2UCI5 ()
  • B800CLOZ250V2UCI0 ()

  • Total Volume: 5 Milliliter
CLOZ 250 V2 UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
CLOZAPINE 1000 NG/ML V2
UTAK LABORATORIES, INC.
CLOZ 1000 V2 UCI
In Commercial Distribution

  • B800CLOZ1000V2UCI5 ()
  • B800CLOZ1000V2UCI0 ()

  • Total Volume: 5 Milliliter
CLOZ 1000 V2 UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
CCDKM QC LEVEL 1 V2
UTAK LABORATORIES, INC.
CCDKM QC 1 V2 WB UK
In Commercial Distribution

  • B800CCDKMQC1V2WBUK5 ()
  • B800CCDKMQC1V2WBUK0 ()

  • Total Volume: 3 Milliliter
CCDKM QC 1 V2 WB UK

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CALIBRATOR LEVEL 4 V2
UTAK LABORATORIES, INC.
BUS CAL 4 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL4V2DPFMDACC5 ()
  • B800BUSCAL4V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 4 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control
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