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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Bitewing Bite Blocks, Red, V2
PLASDENT CORPORATION
XR-0941
In Commercial Distribution

  • D832XR09410 ()
  • D832XR09411 ()
XR-0941

  • Dental x-ray system beam alignment device
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
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
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 Software - Synergy
NATUS NEUROLOGY INCORPORATED
828-080100
In Commercial Distribution

  • 00382830062206 ()


  • 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
Probe holder, (V2) Biim Ultrasound
Biim Ultrasound AS
P001137
In Commercial Distribution

  • 07090045490051 ()
  • 07090045490105 ()
  • 07090045490297 ()
P001137

  • Extracorporeal ultrasound imaging transducer, hand-held
  • Hand-held ultrasound imaging system, body-surface
RIC700 MP Gold QUG(V2)
Yeasound (Xiamen) Hearing Technology Co., Ltd
RIC700 MP
In Commercial Distribution

  • 06977189200870 ()


  • Air-conduction hearing aid, receiver-in-the-ear
V2 Bladed Obturator and Seal
Covidien LP
179103P
In Commercial Distribution

  • 10884521081376 ()
  • 20884521081373 ()

  • Outer Diameter: 5 Millimeter
  • Outer Diameter: 12 Millimeter


  • Laparoscopic multi-instrument access port, single-use
V2 Bladed Obturator and Seal
Covidien LP
179102P
In Commercial Distribution

  • 10884521081369 ()
  • 20884521081366 ()

  • Outer Diameter: 5 Millimeter
  • Outer Diameter: 11 Millimeter


  • Laparoscopic multi-instrument access port, single-use
V2 SPECIMEN COLLECTION MANIFOLD KIT
STRYKER CORPORATION
0750200000
In Commercial Distribution

  • 37613327566162 ()
0750200000

  • Surgical fluid/smoke waste management system
ANCHOR INSERTER INNER TUBE V2
ZIMMER BIOMET INC
230H1002
In Commercial Distribution

  • 00887868227332 ()


  • Spinal dynamic-stabilization system
ANCHOR INSERTER OUTER TUBE V2
ZIMMER BIOMET INC
230H1001
In Commercial Distribution

  • 00887868227325 ()


  • Spinal dynamic-stabilization system
Versaport V2 Trocar 3/bx
STERILMED, INC.
AUT179094-3
Not in Commercial Distribution

  • 20888551044292 ()
AUT179094-3

  • Laparoscopic trocar blade, reprocessed
moorFLPI2- Measurement PC Software V2
MOOR INSTRUMENTS LIMITED
2
In Commercial Distribution

  • 15060484490126 ()


  • Cutaneous microcirculation laser Doppler imaging device
SONALLEVE MR-HIFU V2 INGENIA 3T
Profound Medical Inc
451000080796
In Commercial Distribution

  • 07540281000267 ()
451000080796

  • Therapeutic oncological/gynaecological ultrasound system
SONALLEVE MR-HIFU V2 INGENIA 1.5T
Profound Medical Inc
451000080786
In Commercial Distribution

  • 07540281000250 ()
451000080786

  • Therapeutic oncological/gynaecological ultrasound system
SONALLEVE MR-HIFU V2 ACHIEVA 3T
Profound Medical Inc
451000080776
In Commercial Distribution

  • 07540281000243 ()
451000080776

  • Therapeutic oncological/gynaecological ultrasound system
SONALLEVE MR-HIFU V2 ACHIEVA 1.5T
Profound Medical Inc
451000080766
In Commercial Distribution

  • 07540281000236 ()
451000080766

  • Therapeutic oncological/gynaecological ultrasound system
High frequency diagnostic x-ray generator
SEDECAL
SHFR800
In Commercial Distribution

  • 08436046003439 ()
V2

  • Diagnostic x-ray system generator, stationary
High frequency diagnostic x-ray generator
SEDECAL
SHFR600
In Commercial Distribution

  • 08436046003422 ()
V2

  • Diagnostic x-ray system generator, stationary
High frequency diagnostic x-ray generator
SEDECAL
SHFR500
In Commercial Distribution

  • 08436046003415 ()
V2

  • Diagnostic x-ray system generator, stationary
High frequency diagnostic x-ray generator
SEDECAL
SHFR400
In Commercial Distribution

  • 08436046003408 ()
V2

  • Diagnostic x-ray system generator, stationary
High frequency diagnostic x-ray generator
SEDECAL
SHFR300
In Commercial Distribution

  • 08436046003392 ()
V2

  • Diagnostic x-ray system generator, stationary
High frequency diagnostic x-ray generator
SEDECAL
SHFR200
In Commercial Distribution

  • 08436046003385 ()
V2

  • Diagnostic x-ray system generator, stationary
High frequency diagnostic x-ray generator
SEDECAL
SHFR100
In Commercial Distribution

  • 08436046003378 ()
V2

  • Diagnostic x-ray system generator, stationary
CABLE,12,RESUABLE,CAMTRONICS,PDM,V2
MEDLINE INDUSTRIES, INC.
64042061
In Commercial Distribution

  • 10193489059434 ()
  • 20193489059431 ()

  • Length: 12 Feet
64042061

  • Invasive-pressure external transducer, single-use
MTS 4V MANIFOLD V2 MOUNT CLEMENS
MEDLINE INDUSTRIES, INC.
60131194
In Commercial Distribution

  • 20193489046752 ()
  • 10193489046755 ()
60131194

  • Angiography kit
11q24 in Texas Red Spectrum v2
CYTOCELL LIMITED
MPD20991
In Commercial Distribution

  • 05055844909182 ()


  • Assay development analyte-specific reagent IVD
TROCAR VERSAPORT V2 W/ FIXATION CANNULA
STERILMED, INC.
AUT179094F
Not in Commercial Distribution

  • 10888551013154 ()
AUT179094F

  • Laparoscopic trocar blade, reprocessed
Grael v2 System with PSG software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001771 ()
9028-0002-02

  • Polysomnograph
Somte PSG v2 System, No software
COMPUMEDICS LIMITED
Somte PSG v2
In Commercial Distribution

  • 09342451001368 ()
9023-0002-01

  • Polysomnograph
Grael EEG v2 System - no software
COMPUMEDICS LIMITED
Grael EEG
In Commercial Distribution

  • 09342451001252 ()
9028-0003-02

  • Electroencephalograph
BioButton Cold Seal Adhesive V2 (ADH-CS)
BIOINTELLISENSE, INC.
ADH-CS-10771
In Commercial Distribution

  • 00850005949534 ()
  • 00850005949541 ()
  • 00850005949510 ()
  • 10850005949517 ()
  • 20850005949514 ()
  • 00850005949527 ()
  • 10850005949524 ()
N/A

  • Dressing-fixation skin adhesive tape, non-silicone
Apnea Guard Starter Kit 2L2M1H (V2)
ADVANCED BRAIN MONITORING, INC.
AG25-1012
In Commercial Distribution

  • 00850015266041 ()


  • Silicone dental impression material
Apnea Guard Starter Kit 1L3M1H (V2)
ADVANCED BRAIN MONITORING, INC.
AG25-1009
In Commercial Distribution

  • 00850015266034 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Apnea Guard Starter Kit 1L2M2H (V2)
ADVANCED BRAIN MONITORING, INC.
AG25-1015
In Commercial Distribution

  • 00850015266386 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Apnea Guard Resupply Kit 5L10M20H (V2)
ADVANCED BRAIN MONITORING, INC.
AG25-1014
In Commercial Distribution

  • 00850015266379 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Apnea Guard Starter Kit 1L3M6H (V2)
ADVANCED BRAIN MONITORING, INC.
AG25-1013
In Commercial Distribution

  • 00850015266362 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
NUP98 Distal in FITC Spectrum V2
CYTOCELL LIMITED
MPH57992
In Commercial Distribution

  • 05055844934207 ()


  • Assay development analyte-specific reagent IVD
11cen in Aqua Spectrum v2 (ASR)
CYTOCELL LIMITED
MPD20993
In Commercial Distribution



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



  • Assay development analyte-specific reagent IVD
MAF v2 in Aqua Spectrum (ASR)
CYTOCELL LIMITED
MPD22713
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
MLL Proximal v2 in FITC Spectrum
CYTOCELL LIMITED
MPD33452
In Commercial Distribution

  • 05055844909601 ()


  • Assay development analyte-specific reagent IVD
MAF v2 in Texas Red Spectrum
CYTOCELL LIMITED
MPH22701
In Commercial Distribution

  • 05055844911291 ()


  • Assay development analyte-specific reagent IVD
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