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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VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, complete
icotec AG
42-700
In Commercial Distribution

  • 07640172552438 ()
42-700

  • Device sterilization/disinfection container, reusable
ECG Electrode Monitoring Radiolucent Cloth White 5/Pack CA/1000 Not Made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
49996
In Commercial Distribution

  • 30885632398203 ()
  • 20885632398206 ()
  • 10885632398209 ()


  • Electrocardiographic electrode, single-use
ECG Electrode Monitoring Radiolucent Cloth White 3/Pack CA/600 Not Made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
49997
In Commercial Distribution

  • 30885632398197 ()
  • 20885632398190 ()
  • 10885632398193 ()


  • Electrocardiographic electrode, single-use
ECG Electrode Monitoring Radiolucent Foam White 3/Pack CA/600 Not Made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
49994
In Commercial Distribution

  • 30885632398180 ()
  • 20885632398183 ()
  • 10885632398186 ()


  • Electrocardiographic electrode, single-use
ECG Electrode Monitoring Radiolucent Foam White 50/Pack CA/1000 Not Made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
49993
In Commercial Distribution

  • 30885632398173 ()
  • 20885632398176 ()
  • 10885632398179 ()


  • Electrocardiographic electrode, single-use
ECG Electrode Monitoring Radiolucent Foam White 5/Pack CA/1000 Not Made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
49995
In Commercial Distribution

  • 30885632398142 ()
  • 20885632398145 ()
  • 10885632398148 ()


  • Electrocardiographic electrode, single-use
SUCTION TUBE 10'OPAQUE BLUE NS W/ADAPT 1/4"ID X 10' L/F 25/CA
ACE SURGICAL SUPPLY CO., INC.
0034245
In Commercial Distribution

  • 00614950013005 ()

  • Length: 10 Feet
0034245

  • Suction/irrigation tubing, single-use
Standard Imaging QA StereoChecker is a daily machine quality assurance checks for the Cyberknife (Accuray, Sunnyvale CA).
STANDARD IMAGING INC.
91349
In Commercial Distribution

  • 00850019946123 ()
91349

  • Accelerator system quality assurance device
SCHWARTZ FORCEPS 25° ANGLED, SMOOTH, CA. 5.0 N 10 X 1.7 MM, NOT FOR NEURO AND CARDIO
Gimmi GmbH
AC.1130.05
In Commercial Distribution

  • 04049047685524 ()
AC.1130.05

  • Scalp wound clip
SCHWARTZ FORCEPS 25° ANGLED, SMOOTH, CA. 7.8 N 10 X 1.7 MM, NOT FOR NEURO AND CARDIO
Gimmi GmbH
AC.1130.02
In Commercial Distribution

  • 04049047675754 ()
AC.1130.02

  • Scalp wound clip
S1,400DT,Dual CA,1000mm,850mm,(LCH 3P SA,SYoke,3P Lt)(LCH 3P SA,SYoke,3P Lt)
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007893 ()
C14D3244

  • Operating room light
S1,400 DT,Dl CA,1000,850,(Nl 3P SA, Dl YK,3P Lt) Sgl MH for Barco Monitor
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007824 ()
C14D323K

  • Operating room light
S1,400 DT,Dual CA, 1750,1600, (LCH 9P SA, S/yoke 9PLight)(LCH 3P SA SY 3P Light
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007565 ()
C14D8764

  • Operating room light
S1 600DT Trpl CA 1150 1000 850 3p Norm DY SL-30M, 9P Norm DY SL-30m, Sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003529 ()
C16T432351

  • Operating room light
S1 200DT Dual CA 1000/850 LCH 3P Sgl yok 9P SL30M, Sgl MH Barco Conv/Integration
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003055 ()
C12D326L

  • Operating room light
Series 1, 200 DT Triple CA 1150, 1000, 850, 3P SA 30M, 3P SA 30M, Gen2 MH-A
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003222 ()
C12T432331

  • Operating room light
Series 1, 600 DT Triple CA 1150, 1000, 850, 3P SA 30M, 3P SA 30M, Gen2 MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001907 ()
C16T432331

  • Operating room light
Series 1, 200 DT, Dual CA 1150,1000, Gen 1, 3P SA, i30 , Gen 1, 3P SA, i30
Amico Clinical Solutions Corp
iCE30
In Commercial Distribution

  • 00684706001556 ()
C12D43EE

  • Operating room light
Series 1 200 DT Dual CA, 1150,1000, 3P SA Dual yoke 30M, sngl Monitor SA sngl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001501 ()
C12D4331

  • Operating room light
S1,300 DT Tpl CA,1150,1000, 850(Normal 3P SA, Dual yok 3P Light SA x2, Sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007497 ()
C13T43233J

  • Operating room light
Series 1, 300 DT Triple CA 1150, 1000, 850, 3P SA 30M, 3P SA 30M, Gen2 MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007367 ()
C13T432331

  • Operating room light
Series 3 700 DT sgl dual sgl CA 1300/1300/1150/1000 2x mon/2x SL-30M system
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007244 ()
C37SDS55431133

  • Operating room light
Series 1 300 DT Dual CA, 1150,1000, 3P SA Dual yoke 30M, sngl Monitor SA sngl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006308 ()
C13D4331

  • Operating room light
S3 400DT blnk dual Sgl CA 2x1750 1600 9P DY 30M Sgl MH Barco integrat Rad shield
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006216 ()
C34BDS8875LR

  • Operating room light
S3 No DT 2x1150 1000 850 CA 2x Sgl MH 1x 3p DY SL-30M 9p DY SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006100 ()
C3XSDS43241531

  • Operating room light
Series 1, 200 DT Triple CA 1150, 1000, 850, 3P SA 30M, 3P SA 30M, Barco MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003840 ()
C12T43233K

  • Operating room light
Series 1 600 DT Dual CA, 1150,1000, 3P SA Dual yoke 30M, sngl Monitor SA sngl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003833 ()
C16D4331

  • Operating room light
S3 400DT blnk dual Sgl CA 2x1750 1600 3P DY 30M Sgl MH Barco integrat Rad shield
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003765 ()
C34BDS8873LR

  • Operating room light
GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 450 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044345008
In Commercial Distribution

  • 08426951070848 ()
00044345008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 300 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044330008
In Commercial Distribution

  • 08426951070831 ()
00044330008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 150 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044315008
In Commercial Distribution

  • 08426951070824 ()
00044315008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 75 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044307508
In Commercial Distribution

  • 08426951070817 ()
00044307508

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
REUSABLE GEL PACK SMALL 4.75X6 IN GLYCERINE CA 24 REUSABLE Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51792
In Commercial Distribution

  • 20885632413916 ()
  • 10885632413919 ()


  • Hot/cold therapy pack, reusable
Grounding Pad Split No Cord Adult Multiple Green CA/200 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
55554
In Commercial Distribution

  • 20885632412896 ()
  • 30885632412893 ()
  • 10885632412899 ()


  • Electrosurgical return electrode, single-use
Grounding Pad Split XL Cord Adult Multiple Green CA/100 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
55553
In Commercial Distribution

  • 20885632412889 ()
  • 30885632412886 ()
  • 10885632412882 ()


  • Electrosurgical return electrode, single-use
Electrode Infant Prewired Infant CA/100 Radiolucent 3 per pack Not made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
55550
In Commercial Distribution

  • 20885632412865 ()
  • 10885632412868 ()


  • Electrocardiographic electrode, single-use
Leur Adapter Standard Standard Polypropylene Green Single Use CA/1000 Not made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
50012
In Commercial Distribution

  • 20885632401333 ()
  • 10885632401336 ()
  • 30885632401330 ()


  • Blood collection tube holder/needle
BREATHING CIRCUIT SINGLE LIMB SINGLE-USE 90 INCH POLYURETHANE CA/20 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
ABC1001
In Commercial Distribution

  • 20885632424417 ()
  • 10885632424410 ()


  • Anaesthesia breathing circuit, single-use
REUSABLE GEL PACK LARGE 4.5X9 IN GLYCERINE CA 24 REUSABLE Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51791
In Commercial Distribution

  • 20885632413909 ()
  • 10885632413902 ()


  • Hot/cold therapy pack, reusable
Tube Holder Standard Standard Polypropylene Transparent Single Use CA/1000 Not made with Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
50013
In Commercial Distribution

  • 20885632401340 ()
  • 10885632401343 ()
  • 30885632401347 ()


  • Blood collection tube holder, single-use
IRRIGATION BOTTLE STERILE WATER 100ML PP CLEAR CA/48 STERILE NOT MADE WITH NATURAL RUBBER LATEX HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49151
In Commercial Distribution

  • 20885632395908 ()
  • 10885632395901 ()


  • Wound irrigation sterile water
IRRIGATION BOTTLE STERILE WATER 250ML PP CLEAR CA/24 STERILE NOT MADE WITH NATURAL RUBBER LATEX HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49148
In Commercial Distribution

  • 20885632395878 ()
  • 10885632395871 ()


  • Wound irrigation sterile water
MASTER TUBES SHORT BLUE [Ø4.7MM] (10 UNITS)
SOADCO, S.L.
20 03 13 C-A
In Commercial Distribution

  • 08435451647740 ()
20 03 13 C-A

  • Surgical torque wrench, reusable
MASTER TUBES SHORT BLUE [Ø4.7MM] (10 UNITS)
SOADCO, S.L.
20 03 13 C-A
In Commercial Distribution

  • 08435451642622 ()
20 03 13 C-A

  • Surgical torque wrench, reusable
MASTER TUBES SHORT BLUE [Ø4.7MM] (10 UNITS)
SOADCO, S.L.
20 03 13 C-A
In Commercial Distribution

  • 08435451639172 ()
20 03 13 C-A

  • Surgical torque wrench, reusable
DIGITAL THERM BOXED
COMPASS HEALTH BRANDS CORP.
70033B
In Commercial Distribution

  • 50076855700339 ()
  • 30076855700335 ()
  • 40076855700332 ()
  • 00076855700334 ()


  • Intermittent electronic patient thermometer
TEMP*QWIK THERMOMETER CARDED
COMPASS HEALTH BRANDS CORP.
70032
In Commercial Distribution

  • 40076855700325 ()
  • 00076855700327 ()
  • 30076855700328 ()
  • 50076855700322 ()


  • Liquid-crystal patient thermometer, reusable
NA+/K+/CA++/CL- Electrode fill solution. In vitro diagnostics material for use with RAPIDLab® 1200 electrodes.
Siemens Healthcare Diagnostics Inc.
10376882
In Commercial Distribution

  • 00630414570501 ()
  • 00630414010243 ()
10376882

  • Ion selective electrode (ISE) reference solution IVD, reagent
RAPIDPOINT® 350 Reagent Module pH / pCO2 / pO2 / Na+ / K+ / Cl- / Ca++ for use with Rapidpoint 350 analyzers
Siemens Healthcare Diagnostics Inc.
10375806
In Commercial Distribution

  • 00630414566290 ()
10375806

  • Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
Foam Positioner Straps Blue White Polyurethane Foam Blue White CA/20 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49493
In Commercial Distribution

  • 20885632448703 ()
  • 10885632448706 ()


  • Freestanding patient positioner, single-use
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