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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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NA - 00817577021525

HANDLE WITH QCK CNCT
Exactech, Inc.
1100-0000
In Commercial Distribution

  • 00817577021525 ()
1100-0000

  • Surgical instrument handle, non-torque-limiting

CENTRIMAG® BACK-UP CONSOLE WITH BATTERIES - 07640135140887

BACK-UP CONSOLE WITH BATTERIES
Thoratec Switzerland GmbH
201-90220
In Commercial Distribution

  • 07640135140887 ()
201-90220

  • Cardiopulmonary bypass system centrifugal pump backup drive unit

CENTRIMAG® BACK-UP CONSOLE WITH BATTERIES - 07640135140870

BACK-UP CONSOLE WITH BATTERIES
Thoratec Switzerland GmbH
201-90200
In Commercial Distribution

  • 07640135140870 ()
201-90200

  • Cardiopulmonary bypass system centrifugal pump backup drive unit

CENTRIMAG® Back-Up Console with Batteries - 07640135140863

Back-Up Console with Batteries
Thoratec Switzerland GmbH
102966
In Commercial Distribution

  • 07640135140863 ()
102966

  • Cardiopulmonary bypass system centrifugal pump backup drive unit

Pinnacle - 00817650026195

Chassis With OBS Sensors
Harmar Summit, LLC
Pinnacle, Rave, Leaf
In Commercial Distribution

  • 00817650026195 ()
SSL1200

  • Stairlift, chair

MAXO2+ - 00817770020943

Analyzer with Optiflow Jr.
MAXTEC, LLC
R219P17-003
Not in Commercial Distribution

  • 00817770020943 ()


  • Respiratory oxygen monitor, line-powered

BIONIX RADIATION THERAPY - 00817740020713

TRIVAC WITH BOLSTER CUSHION
Bionix Radiation Therapy, LLC
SVRT-7650
Not in Commercial Distribution

  • 00817740020713 ()
SVRT-7650

  • Radiological whole-body positioner

Curaplex - 00817617022925

Non-Rebreather with vent, Adult,
BOUND TREE MEDICAL, LLC
301-181EA
In Commercial Distribution

  • 00817617023403 ()
  • 00817617022925 ()
301-181EA

  • Non-rebreathing oxygen face mask

OxyTrach™ - 10620974000621

OxyTrach with 7ft tubing
Southmedic Incorporated
OAT-1025
In Commercial Distribution

  • 00620974000624 ()
  • 10620974000621 ()
OAT-1025

  • Vortex oxygen face mask

OxyMask™ - 10620974000256

OxyMask with 14ft tubing
Southmedic Incorporated
OM-1125-14
In Commercial Distribution

  • 00620974000259 ()
  • 10620974000256 ()
OM-1125-14

  • Vortex oxygen face mask

OxyMask™ - 10620974000249

OxyMask with 7ft tubing
Southmedic Incorporated
OM-1125-8
In Commercial Distribution

  • 00620974000242 ()
  • 10620974000249 ()
OM-1125-8

  • Vortex oxygen face mask

the Wand Handpiece - 10618874000131

WA Handpiece with needle
Milestone Scientific Inc.
WA-2050-305
In Commercial Distribution

  • 10618874000131 ()
  • 00618874503055 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand Handpiece - 10618874000124

WA Handpiece with needle
Milestone Scientific Inc.
WA-2050-301
In Commercial Distribution

  • 10618874000124 ()
  • 00618874503017 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand Handpiece - 10618874000117

WA Handpiece with needle
Milestone Scientific Inc.
WA-2050-2725
In Commercial Distribution

  • 10618874000117 ()
  • 00618874502713 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand STA Handpiece - 10618874000056

STA Handpiece with needle
Milestone Scientific Inc.
STA-5050-305
In Commercial Distribution

  • 10618874000056 ()
  • 00618874603052 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand STA Handpiece - 10618874000049

STA Handpiece with needle
Milestone Scientific Inc.
STA-5050-301
In Commercial Distribution

  • 10618874000049 ()
  • 00618874603014 ()


  • Dental computer assisted anaesthesia injection handpiece

the Wand STA Handpiece - 10618874000032

STA Handpiece with needle
Milestone Scientific Inc.
STA-5050-2725
In Commercial Distribution

  • 10618874000032 ()
  • 00618874602710 ()


  • Dental computer assisted anaesthesia injection handpiece

Spine Instruments - 07630971237247

Flat bender with pins
Medacta International SA
03.51.10.0416
In Commercial Distribution

  • 07630971237247 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

PULSOX-300i - 00817770020639

Oximeter with Finger Probe
MAXTEC, LLC
R204P17
Not in Commercial Distribution

  • 00817770020639 ()


  • Pulse oximeter

PULSOX-300 - 00817770020608

Oximeter with Finger Probe
MAXTEC, LLC
R204P16
Not in Commercial Distribution

  • 00817770020608 ()


  • Pulse oximeter
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