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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GPRO P1,Gutta-percha Obturation Heating Pen Tips included: 40mm/04 taper, 45mm/04 taper, 55mm/06 taper, 55mm/08 taper
Beyes Dental Canada Inc
GP2003
In Commercial Distribution

  • 00990010302211 ()
GPRO P1

  • Endodontic obturation system handpiece, heat conducting
Keyless, precise, open-guided surgery kit, designed to allow for more accurate, efficient, and safe surgery with minimal error and drill heating.
Shinhung MST Co., Ltd.
CDW
In Commercial Distribution

  • 08806343921185 ()


  • Fixture/appliance dental drill bit, reusable
Arm Warming Sleeve Large
Avacore Technologies, Inc.
WU-200L
In Commercial Distribution

  • 00851137008014 ()
  • 10851137008011 ()
WU-200L

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Warm UP Control Unit
Avacore Technologies, Inc.
WU-20
In Commercial Distribution

  • 00851137008007 ()
WU-20

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
No Description
Tec Com Medizintechnik GmbH
NEO
In Commercial Distribution

  • 04260647540314 ()
8289830

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Tecotherm NEO cooling system
INSPIRATION HEALTHCARE LIMITED
NEO
In Commercial Distribution

  • 05060206921221 ()


  • External circulating-fluid core temperature regulation system control unit, heating/cooling
No Description
TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung
TECOTHERM NEO
In Commercial Distribution

  • 04260498580002 ()


  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Surface Warming & Cooling System
ADROIT MEDICAL SYSTEMS, INC.
A3
In Commercial Distribution

  • 10615089310208 ()
3102-0001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Patient warming and cooling device
Gentherm Medical, LLC
233
In Commercial Distribution

  • 10613031871074 ()

  • Weight: 59.5 Kilogram
  • Weight: 131 Pound
  • Height: 95.3 Centimeter
  • Height: 37.5 Inch
  • Depth: 43.2 Centimeter
  • Depth: 17.0 Inch
  • Width: 43.2 Centimeter
  • Width: 17.0 Inch
87107

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Thermal Regulating System
Gentherm Medical, LLC
233
In Commercial Distribution

  • 10613031861075 ()

  • Weight: 59.5 Kilogram
  • Weight: 131 Pound
  • Height: 95.3 Centimeter
  • Depth: 43.2 Centimeter
  • Width: 43.2 Centimeter
  • Height: 37.5 Inch
  • Depth: 17.0 Inch
  • Width: 17.0 Inch
86107

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Temperature management system used to lower or raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.
Gentherm Medical, LLC
25-01
In Commercial Distribution

  • 10613031860009 ()

  • Weight: 131 Pound
  • Height: 37.5 Inch
  • Depth: 17.0 Inch
  • Width: 17.0 Inch
86000

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
No Description
STRYKER CORPORATION
8001
In Commercial Distribution

  • 07613327277555 ()
8001-000-001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory kit for the thermoregulation System
BELMONT INSTRUMENT CORPORATION
200-00410
In Commercial Distribution

  • 07290012127991 ()
200-00410

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory kit for the thermoregulation System
BELMONT INSTRUMENT CORPORATION
200-00400
In Commercial Distribution

  • 07290012127984 ()
200-00400

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory kit for the thermoregulation System
BELMONT INSTRUMENT CORPORATION
200-00330
In Commercial Distribution

  • 07290012127977 ()
200-00330

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory kit for Allon/CritiCool systems
BELMONT INSTRUMENT CORPORATION
200-00320
In Commercial Distribution

  • 07290012127960 ()
200-00320

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory kit for the thermoregulation System
BELMONT INSTRUMENT CORPORATION
200-00310
In Commercial Distribution

  • 07290012127953 ()
200-00310

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory kit for the thermoregulation System
BELMONT INSTRUMENT CORPORATION
200-00300
In Commercial Distribution

  • 07290012127946 ()
200-00300

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03548
In Commercial Distribution

  • 07290012127380 ()
  • 77290012127389 ()
  • 17290012127387 ()
500-03548

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03541
In Commercial Distribution

  • 07290012127373 ()
  • 17290012127370 ()
  • 77290012127372 ()
500-03541

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03536
In Commercial Distribution

  • 07290012127342 ()
  • 17290012127349 ()
  • 77290012127341 ()
500-03536

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03525
In Commercial Distribution

  • 07290012127328 ()
  • 17290012127325 ()
  • 77290012127327 ()
500-03525

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 systems. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03125
In Commercial Distribution

  • 07290012127304 ()
  • 37290012127305 ()
500-03125

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 system. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03121
In Commercial Distribution

  • 07290012127298 ()
  • 37290012127299 ()
500-03121

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon systems. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03118
In Commercial Distribution

  • 07290012127281 ()
  • 37290012127282 ()
500-03118

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 systems. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03363
In Commercial Distribution

  • 07290012127274 ()
  • 27290012127278 ()
  • 57290012127279 ()
500-03363

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
No Description
BELMONT INSTRUMENT CORPORATION
500-03166
In Commercial Distribution

  • 07290012127267 ()
  • 27290012127261 ()
  • 57290012127262 ()
500-03166

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 systems. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03160
In Commercial Distribution

  • 07290012127250 ()
  • 27290012127254 ()
  • 57290012127255 ()
500-03160

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 system. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03153
In Commercial Distribution

  • 07290012127243 ()
  • 27290012127247 ()
  • 57290012127248 ()
500-03153

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool /Allon 2001 systems.
BELMONT INSTRUMENT CORPORATION
500-03148
In Commercial Distribution

  • 07290012127236 ()
  • 27290012127230 ()
  • 57290012127231 ()
500-03148

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 systems. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03141
In Commercial Distribution

  • 07290012127229 ()
  • 27290012127223 ()
  • 57290012127224 ()
500-03141

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 systems. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03136
In Commercial Distribution

  • 07290012127212 ()
  • 27290012127216 ()
  • 57290012127217 ()
500-03136

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 systems. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03131
In Commercial Distribution

  • 07290012127205 ()
  • 27290012127209 ()
  • 57290012127200 ()
500-03131

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03521
In Commercial Distribution

  • 07290012127199 ()
  • 17290012127196 ()
  • 77290012127198 ()
500-03521

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03518
In Commercial Distribution

  • 07290012127182 ()
  • 17290012127189 ()
  • 77290012127181 ()
500-03518

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
500-03500
In Commercial Distribution

  • 07290012127175 ()
  • 17290012127172 ()
  • 77290012127174 ()
500-03500

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
CritiCool Mini Unit
BELMONT INSTRUMENT CORPORATION
200-00336
In Commercial Distribution

  • 07290107581301 ()
200-00336

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
No Description
BELMONT INSTRUMENT CORPORATION
200-00236
In Commercial Distribution

  • 07290107581110 ()
200-00236

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
No Description
BELMONT INSTRUMENT CORPORATION
200-00263
In Commercial Distribution

  • 07290107581103 ()
200-00263

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Pediatric 122-135cm (single )
Not in Commercial Distribution

  • 07290107580687 ()
  • 17290107580684 ()
500-T3548

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
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