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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UNIV,ROD,PREBENT,CO,5.5X70
Choice Spine, LP
MC40-P070
In Commercial Distribution

  • 00840996109444 ()

  • Length: 70 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
UNIV,ROD,PREBENT,CO,5.5X65
Choice Spine, LP
MC40-P065
In Commercial Distribution

  • 00840996109437 ()

  • Length: 65 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
UNIV,ROD,PREBENT,CO,5.5X60
Choice Spine, LP
MC40-P060
In Commercial Distribution

  • 00840996109420 ()

  • Length: 60 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
UNIV,ROD,PREBENT,CO,5.5X55
Choice Spine, LP
MC40-P055
In Commercial Distribution

  • 00840996109413 ()

  • Length: 55 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
UNIV,ROD,PREBENT,CO,5.5X50
Choice Spine, LP
MC40-P050
In Commercial Distribution

  • 00840996109406 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
UNIV,ROD,PREBENT,CO,5.5X45
Choice Spine, LP
MC40-P045
In Commercial Distribution

  • 00840996109390 ()

  • Length: 45 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
UNIV,ROD,PREBENT,CO,5.5X40
Choice Spine, LP
MC40-P040
In Commercial Distribution

  • 00840996109383 ()

  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
UNIV,ROD,PREBENT,CO,5.5X35
Choice Spine, LP
MC40-P035
In Commercial Distribution

  • 00840996109376 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
UNIV,ROD,PREBENT,CO,5.5X30
Choice Spine, LP
MC40-P030
In Commercial Distribution

  • 00840996109369 ()

  • Length: 30 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Co 57 Neurologica Line Source
RADQUAL, LLC
BM83-49
In Commercial Distribution

  • 00850020470525 ()


  • Radiographic image marker, manual
RIDID ENDOSCOPE,STERRAD NX CO
PENTAX OF AMERICA, INC.
9109
In Commercial Distribution

  • 04961333240555 ()

  • Angle: 70.0 degree
  • Outer Diameter: 8.5 Millimeter


  • Rigid optical nasopharyngoscope
Co 57 Flexible Line Source
RADQUAL, LLC
BM83-10
In Commercial Distribution

  • 00850020470495 ()


  • Radiographic image marker, manual
Co 60 20cc Multidose Vial
RADQUAL, LLC
BM06V-20-60
In Commercial Distribution

  • 00850020470402 ()


  • Radionuclide source, quality assurance
Co 60 10cc Multidose Vial
RADQUAL, LLC
BM06V-10-60
In Commercial Distribution

  • 00850020470358 ()


  • Radionuclide source, quality assurance
Co 60 5cc Multidose Vial
RADQUAL, LLC
BM06V-5-60
In Commercial Distribution

  • 00850020470303 ()


  • Radionuclide source, quality assurance
Square Digirad Phantom Co 57
RADQUAL, LLC
BM05
In Commercial Distribution

  • 00850020470037 ()


  • Nuclear medicine phantom, flood source
AIRCURVE 11 VAUTO USA CO
RESMED PTY LTD
39018
In Commercial Distribution

  • 00619498390182 ()
39018

  • Home BPAP unit
AIRCURVE 11 ASV USA CO
RESMED PTY LTD
39012
In Commercial Distribution

  • 00619498390120 ()
39012

  • Home BPAP unit
AirSense 11 Elite USA CO
RESMED PTY LTD
39004
In Commercial Distribution

  • 00619498390045 ()
39004

  • Home CPAP unit
AirSense 11 CPAP USA CO
RESMED PTY LTD
39002
In Commercial Distribution

  • 00619498390021 ()
39002

  • Home CPAP unit
AIRSENSE 11 AUTOSET USA CO
RESMED PTY LTD
39000
In Commercial Distribution

  • 00619498394203 ()
  • 00619498390007 ()
39000

  • Home CPAP unit
AIRSENSE 10 AUTOSET 3G CO
RESMED PTY LTD
37402
In Commercial Distribution

  • 00619498374021 ()
37402

  • Home CPAP unit
AIRCURVE 10 ST USA CO
RESMED PTY LTD
37306
In Commercial Distribution

  • 00619498373062 ()
  • 00619498370566 ()
37306

  • Portable electric ventilator
AIRCURVE 10 ASV USA CO
RESMED PTY LTD
37215
In Commercial Distribution

  • 00619498372157 ()
  • 00619498370436 ()
37215

  • Home BPAP unit
AirCurve 10 S USA CO
RESMED PTY LTD
37213
In Commercial Distribution

  • 00619498372133 ()
  • 00619498370467 ()
37213

  • Portable electric ventilator
AIRSENSE 10 AUTOSET USA CO
RESMED PTY LTD
37207
In Commercial Distribution

  • 00619498372072 ()
  • 00619498370283 ()
37207

  • Home CPAP unit
AIRSTART 10 CPAP AMER CO
RESMED PTY LTD
37201
In Commercial Distribution

  • 00619498372010 ()
37201

  • Home CPAP unit
AirCurve 10 ST-A 3G CO
RESMED PTY LTD
150
In Commercial Distribution

  • 00619498282197 ()
28219

  • Home BPAP unit
IM TIBIAL RES. REAMER CO
Exactech, Inc.
209-89-05
In Commercial Distribution

  • 10885862056825 ()
209-89-05

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Mouth Gag for CO 2-LASER
Karl Storz GmbH & Co. KG
744500L
In Commercial Distribution

  • 04048551196151 ()


  • Mouth gag, adjustable, reusable
Controller/Mobile Air Chair Co
Tridien Medical
Air Chair
In Commercial Distribution

  • 00841965103272 ()
77-SM150-CH

  • Alternating-pressure chair cushion system
PHILIPS CO TEMPERATURE PROBE 93523
Edwards Lifesciences LLC
23001A
In Commercial Distribution

  • 00690103219104 ()
23001A

  • General-purpose patient temperature probe, reusable
MARGIN TRIMMER, DE, #79-80, CO
NORDENT MANUFACTURING INC
CEMT79-80
In Commercial Distribution

  • 00840018634343 ()


  • Margin finishing dental file/rasp, reusable
WEDELSTADT CHISEL, DE, #3-4 CO
NORDENT MANUFACTURING INC
CEMT3-4
In Commercial Distribution

  • 00840018634305 ()


  • Margin finishing dental file/rasp, reusable
MINICUP WITH OPI300/METH500/CO
AMERICAN BIO MEDICA CORPORATION
10-12BOX3-030
Not in Commercial Distribution

  • 10694644500018 ()
  • 10694644550013 ()
10-12BOX3-030

  • Multiple therapeutic drugs/drugs of abuse IVD, calibrator
UNI Hex Cr Co Cylinder
INTRA-LOCK INTERNATIONAL, INC.
UHCCC
In Commercial Distribution

  • D742UHCCC0 ()
UHCCC

  • Dental implant system
CLASSIC CRAFT ZIRLIFE LAB CO-
Peter Brasseler Holdings, LLC
5023984U0
In Commercial Distribution

  • 00887919688099 ()


  • Diamond dental bur, single-use
CERAMICS DENTAL LAB LAB CO-
Peter Brasseler Holdings, LLC
5023740U0
In Commercial Distribution

  • 00887919685265 ()


  • Diamond dental bur, single-use
LP, AHA, 3.0m, HF
Schiller AG
2.410205
In Commercial Distribution

  • 07613365000283 ()
2.410205

  • Electrocardiographic lead set, reusable
Salmonella As Hf, 5ml
HARDY DIAGNOSTICS
294180
Not in Commercial Distribution

  • 00816576022533 ()
294180

  • Multiple Salmonella species culture isolate antigen IVD, reagent
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