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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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AIRSENSE - 00619498372072

AIRSENSE 10 AUTOSET USA CO
RESMED PTY LTD
37207
In Commercial Distribution

  • 00619498372072 ()
  • 00619498370283 ()
37207

  • Home CPAP unit

AIRSTART - 00619498372010

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

  • 00619498372010 ()
37201

  • Home CPAP unit

AIR 11 - 00619498390182

AIRCURVE 11 VAUTO USA CO
RESMED PTY LTD
39018
In Commercial Distribution

  • 00619498390182 ()
39018

  • Home BPAP unit

AIR 11 - 00619498390120

AIRCURVE 11 ASV USA CO
RESMED PTY LTD
39012
In Commercial Distribution

  • 00619498390120 ()
39012

  • Home BPAP unit

AIR 11 - 00619498390045

AirSense 11 Elite USA CO
RESMED PTY LTD
39004
In Commercial Distribution

  • 00619498390045 ()
39004

  • Home CPAP unit

AIR 11 - 00619498390021

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

  • 00619498390021 ()
39002

  • Home CPAP unit

AIR 11 - 00619498390007

AIRSENSE 11 AUTOSET USA CO
RESMED PTY LTD
39000
In Commercial Distribution

  • 00619498394203 ()
  • 00619498390007 ()
39000

  • Home CPAP unit

ForeSight Elite - 00690103219104

PHILIPS CO TEMPERATURE PROBE 93523
Edwards Lifesciences LLC
23001A
In Commercial Distribution

  • 00690103219104 ()
23001A

  • General-purpose patient temperature probe, reusable

NORDENT MANUFACTURING INC - 00840018634343

MARGIN TRIMMER, DE, #79-80, CO
NORDENT MANUFACTURING INC
CEMT79-80
In Commercial Distribution

  • 00840018634343 ()


  • Margin finishing dental file/rasp, reusable

NORDENT MANUFACTURING INC - 00840018634305

WEDELSTADT CHISEL, DE, #3-4 CO
NORDENT MANUFACTURING INC
CEMT3-4
In Commercial Distribution

  • 00840018634305 ()


  • Margin finishing dental file/rasp, reusable

RTCII 2nd gen. - 10694644500018

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

Salvo® Spine System - 10840642139808

Connector, Parallel, C-O, Double, Large
Spine Wave, Inc.
11-7391
In Commercial Distribution

  • 10840642139808 ()
11-7391

  • Bone-screw internal spinal fixation system connector

Salvo® Spine System - 10840642139792

Connector, Parallel, C-O, Double, Medium
Spine Wave, Inc.
11-7390
In Commercial Distribution

  • 10840642139792 ()
11-7390

  • Bone-screw internal spinal fixation system connector

Salvo® Spine System - 10840642139785

Connector, Parallel, C-O, Double, Small
Spine Wave, Inc.
11-7389
In Commercial Distribution

  • 10840642139785 ()
11-7389

  • Bone-screw internal spinal fixation system connector

Millennium - 00190776164102

MAYO CO. DUCT SCP SML
Avalign Technologies, Inc.
1-140140
In Commercial Distribution

  • 00190776164102 ()


  • Gallstone scoop

n.a. - 04048551196151

Mouth Gag for CO 2-LASER
Karl Storz GmbH & Co. KG
744500L
In Commercial Distribution

  • 04048551196151 ()


  • Mouth gag, adjustable, reusable

NA - 10885862056825

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

  • 10885862056825 ()
209-89-05

  • Orthopaedic prosthesis implantation positioning instrument, reusable

LANCER™/THUNDERBOLT™ Pedicle Screw System - 00840996146166

TBOLT,ROD,PREBENT,CO,5.5X200
Choice Spine, LP
MC20-P200
In Commercial Distribution

  • 00840996146166 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 195 Millimeter


  • Bone-screw internal spinal fixation system rod

LANCER™/THUNDERBOLT™ Pedicle Screw System - 00840996146159

TBOLT,ROD,PREBENT,CO,5.5X195
Choice Spine, LP
MC20-P195
In Commercial Distribution

  • 00840996146159 ()

  • Length: 190 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod

LANCER™/THUNDERBOLT™ Pedicle Screw System - 00840996146142

TBOLT,ROD,PREBENT,CO,5.5X190
Choice Spine, LP
MC20-P190
In Commercial Distribution

  • 00840996146142 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 185 Millimeter


  • Bone-screw internal spinal fixation system rod

LANCER™/THUNDERBOLT™ Pedicle Screw System - 00840996146135

TBOLT,ROD,PREBENT,CO,5.5X185
Choice Spine, LP
MC20-P185
In Commercial Distribution

  • 00840996146135 ()

  • Length: 180 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod

LANCER™/THUNDERBOLT™ Pedicle Screw System - 00840996146128

TBOLT,ROD,PREBENT,CO,5.5X180
Choice Spine, LP
MC20-P180
In Commercial Distribution

  • 00840996146128 ()

  • Length: 175 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod

LANCER™/THUNDERBOLT™ Pedicle Screw System - 00840996146111

TBOLT,ROD,PREBENT,CO,5.5X175
Choice Spine, LP
MC20-P175
In Commercial Distribution

  • 00840996146111 ()

  • Length: 170 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod

LANCER™/THUNDERBOLT™ Pedicle Screw System - 00840996146098

TBOLT,ROD,PREBENT,CO,5.5X165
Choice Spine, LP
MC20-P165
In Commercial Distribution

  • 00840996146098 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 160 Millimeter


  • Bone-screw internal spinal fixation system rod

LANCER™/THUNDERBOLT™ Pedicle Screw System - 00840996146081

TBOLT,ROD,PREBENT,CO,5.5X160
Choice Spine, LP
MC20-P160
In Commercial Distribution

  • 00840996146081 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 155 Millimeter


  • Bone-screw internal spinal fixation system rod

LANCER™/THUNDERBOLT™ Pedicle Screw System - 00840996146074

TBOLT,ROD,PREBENT,CO,5.5X155
Choice Spine, LP
MC20-P155
In Commercial Distribution

  • 00840996146074 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 150 Millimeter


  • Bone-screw internal spinal fixation system rod

LANCER™/THUNDERBOLT™ Pedicle Screw System - 00840996146067

TBOLT,ROD,PREBENT,CO,5.5X150
Choice Spine, LP
MC20-P150
In Commercial Distribution

  • 00840996146067 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 145 Millimeter


  • Bone-screw internal spinal fixation system rod

LANCER™/THUNDERBOLT™ Pedicle Screw System - 00840996146050

TBOLT,ROD,PREBENT,CO,5.5X145
Choice Spine, LP
MC20-P145
In Commercial Distribution

  • 00840996146050 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 140 Millimeter


  • Bone-screw internal spinal fixation system rod

LANCER™/THUNDERBOLT™ Pedicle Screw System - 00840996146043

TBOLT,ROD,PREBENT,CO,5.5X140
Choice Spine, LP
MC20-P140
In Commercial Distribution

  • 00840996146043 ()

  • Length: 135 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system rod

LANCER™/THUNDERBOLT™ Pedicle Screw System - 00840996146036

TBOLT,ROD,PREBENT,CO,5.5X135
Choice Spine, LP
MC20-P135
In Commercial Distribution

  • 00840996146036 ()


  • Bone-screw internal spinal fixation system rod

RIGID SCOPES - 04961333240555

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

CARDINAL HEALTH - 10887488869148

STRL KAISER PERMANENTE OF CO
Cardinal Health 200, LLC
SAN45SAKP3
In Commercial Distribution

  • 50887488869146 ()
  • 10887488869148 ()
SAN45SAKP3

  • Angiography kit

Preat - 00842092140031

FIXED COMPLETE CO 8 IMPLANTS
Preat Corporation
7551830
Not in Commercial Distribution

  • 00842092140031 ()
7551830

  • Bar dental precision attachment

Preat - 00842092139950

FIXED COMPLETE CO 7 IMPLANTS
Preat Corporation
7551730
Not in Commercial Distribution

  • 00842092139950 ()
7551730

  • Bar dental precision attachment

Preat - 00842092139905

FIXED COMPLETE CO 6 IMPLANTS
Preat Corporation
7551630
Not in Commercial Distribution

  • 00842092139905 ()
7551630

  • Bar dental precision attachment

Preat - 00842092139851

FIXED COMPLETE CO 5 IMPLANTS
Preat Corporation
7551530
Not in Commercial Distribution

  • 00842092139851 ()
7551530

  • Bar dental precision attachment

Preat - 00842092139837

FIXED COMPLETE CO 4 IMPLANTS
Preat Corporation
7551430
Not in Commercial Distribution

  • 00842092139837 ()
7551430

  • Bar dental precision attachment

Preat - 00842092139806

FIXED COMPLETE CO 3 IMPLANTS
Preat Corporation
7551330
Not in Commercial Distribution

  • 00842092139806 ()
7551330

  • Bar dental precision attachment

Preat - 00842092139769

FIXED COMPLETE CO 2 IMPLANTS
Preat Corporation
7551230
Not in Commercial Distribution

  • 00842092139769 ()
7551230

  • Bar dental precision attachment

CARDINAL HEALTH - 10887488935744

KAISER PERMANENTE OF CO PACK
Cardinal Health 200, LLC
SAN45SAKP4
In Commercial Distribution

  • 50887488935742 ()
  • 10887488935744 ()
SAN45SAKP4

  • Angiography kit

Preat - 00842092172940

ATTACHMENT BAR CO 8 IMPLANTS
Preat Corporation
7551840
Not in Commercial Distribution

  • 00842092172940 ()
7551840

  • Bar dental precision attachment

Preat - 00842092172902

ATTACHMENT BAR CO 7 IMPLANTS
Preat Corporation
7551740
Not in Commercial Distribution

  • 00842092172902 ()
7551740

  • Bar dental precision attachment

Preat - 00842092172889

ATTACHMENT BAR CO 6 IMPLANTS
Preat Corporation
7551640
Not in Commercial Distribution

  • 00842092172889 ()
7551640

  • Bar dental precision attachment

Preat - 00842092172865

ATTACHMENT BAR CO 5 IMPLANTS
Preat Corporation
7551540
Not in Commercial Distribution

  • 00842092172865 ()
7551540

  • Bar dental precision attachment

Preat - 00842092172834

ATTACHMENT BAR CO 3 IMPLANTS
Preat Corporation
7551340
Not in Commercial Distribution

  • 00842092172834 ()
7551340

  • Bar dental precision attachment

Preat - 00842092172810

ATTACHMENT BAR CO 2 IMPLANTS
Preat Corporation
7551240
Not in Commercial Distribution

  • 00842092172810 ()
7551240

  • Bar dental precision attachment

Preat - 00842092173732

ATTACHEMENT BAR CO 4 IMPLANTS
Preat Corporation
7551440
Not in Commercial Distribution

  • 00842092173732 ()
7551440

  • Bar dental precision attachment

SenTech - 00841965103272

Controller/Mobile Air Chair Co
Tridien Medical
Air Chair
In Commercial Distribution

  • 00841965103272 ()
77-SM150-CH

  • Alternating-pressure chair cushion system

Brasseler USA - 00887919688099

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

  • 00887919688099 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919685265

CERAMICS DENTAL LAB LAB CO-
Peter Brasseler Holdings, LLC
5023740U0
In Commercial Distribution

  • 00887919685265 ()


  • Diamond dental bur, single-use
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