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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Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Infant (single)
In Commercial Distribution

  • 07290107580625 ()
  • 17290107580622 ()
500-T3518

  • 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
Adult (single)
Not in Commercial Distribution

  • 07290107580618 ()
  • 17290107580615 ()
500-T3500

  • 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
X-Large Pediatric over 135cm (single)
Not in Commercial Distribution

  • 77290107580266 ()
  • 07290107580267 ()
PED-X2001

  • 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
X-Large Pediatric 122-135 cm (single)
Not in Commercial Distribution

  • 77290107580242 ()
  • 07290107580243 ()
PED-X1001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory connected to the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03541
Not in Commercial Distribution

  • 07290107580212 ()
  • 77290107580211 ()
  • 17290107580080 ()
PED-L2001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03536
Not in Commercial Distribution

  • 07290107580199 ()
  • 77290107580198 ()
PED-L1001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
No Description
BELMONT INSTRUMENT CORPORATION
500-03531
Not in Commercial Distribution

  • 07290107580168 ()
  • 77290107580167 ()
PED-M2001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system. Abody wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Medium1 Pediatric 7-11 kg (single)
Not in Commercial Distribution

  • 07290107580144 ()
  • 77290107580143 ()
PED-M1001

  • 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 104-122 cm (single)
Not in Commercial Distribution

  • 07290107580113 ()
  • 17290107580134 ()
  • 77290107580112 ()
PED-S2001

  • 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 up to 4K (single)
Not in Commercial Distribution

  • 07290107580090 ()
  • 77290107580099 ()
PED-S1001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory kit for Allon 2001 and CritiCool.
BELMONT INSTRUMENT CORPORATION
200-00420
In Commercial Distribution

  • 07290107580007 ()
200-00420

  • 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 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
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 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 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
Total Body Hyperthermia System
Gentherm Medical, LLC
111Z
In Commercial Distribution

  • 10613031861549 ()

  • Weight: 15.2 Kilogram
  • Weight: 33.5 Pound
  • Height: 46.9 Centimeter
  • Height: 18.5 Inch
  • Depth: 38.1 Centimeter
  • Depth: 15 Inch
  • Width: 22.9 Centimeter
  • Width: 9 Inch
86154

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
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.
SSGW50C
In Commercial Distribution

  • 08806343921178 ()


  • General surgical procedure kit, non-medicated, single-use
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.
SSGR57C
In Commercial Distribution

  • 08806343920966 ()


  • General surgical procedure kit, non-medicated, single-use
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.
SSGR50C
In Commercial Distribution

  • 08806343920959 ()


  • General surgical procedure kit, non-medicated, single-use
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.
FMM
In Commercial Distribution

  • 08806343919342 ()


  • General surgical procedure kit, non-medicated, single-use
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.
FDWH
In Commercial Distribution

  • 08806343919328 ()


  • General surgical procedure kit, non-medicated, single-use
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.
ASL
In Commercial Distribution

  • 08806343919311 ()


  • General surgical procedure kit, non-medicated, single-use
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.
FDRH
In Commercial Distribution

  • 08806343919304 ()


  • General surgical procedure kit, non-medicated, single-use
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.
FDMH
In Commercial Distribution

  • 08806343919298 ()


  • General surgical procedure kit, non-medicated, single-use
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.
DE10
In Commercial Distribution

  • 08806343919281 ()


  • General surgical procedure kit, non-medicated, single-use
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.
ADH10
In Commercial Distribution

  • 08806343919274 ()


  • General surgical procedure kit, non-medicated, single-use
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.
NMDW
In Commercial Distribution

  • 08806343919267 ()


  • General surgical procedure kit, non-medicated, single-use
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.
NMDR
In Commercial Distribution

  • 08806343919250 ()


  • General surgical procedure kit, non-medicated, single-use
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.
NMDM
In Commercial Distribution

  • 08806343919243 ()


  • General surgical procedure kit, non-medicated, single-use
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.
GS57
In Commercial Distribution

  • 08806343919236 ()


  • General surgical procedure kit, non-medicated, single-use
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.
GS50
In Commercial Distribution

  • 08806343919229 ()


  • General surgical procedure kit, non-medicated, single-use
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.
HGS57
In Commercial Distribution

  • 08806343919212 ()


  • General surgical procedure kit, non-medicated, single-use
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.
HGS50
In Commercial Distribution

  • 08806343919205 ()


  • General surgical procedure kit, non-medicated, single-use
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.
TP50W
In Commercial Distribution

  • 08806343919199 ()


  • General surgical procedure kit, non-medicated, single-use
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.
TP40W
In Commercial Distribution

  • 08806343919182 ()


  • General surgical procedure kit, non-medicated, single-use
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.
TP45
In Commercial Distribution

  • 08806343919175 ()


  • General surgical procedure kit, non-medicated, single-use
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.
TP35
In Commercial Distribution

  • 08806343919168 ()


  • General surgical procedure kit, non-medicated, single-use
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.
AD10
In Commercial Distribution

  • 08806343919151 ()


  • General surgical procedure kit, non-medicated, single-use
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.
TDW5013
In Commercial Distribution

  • 08806343919144 ()


  • General surgical procedure kit, non-medicated, single-use
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.
TDW5011
In Commercial Distribution

  • 08806343919137 ()


  • General surgical procedure kit, non-medicated, single-use
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.
TDW5010
In Commercial Distribution

  • 08806343919120 ()


  • General surgical procedure kit, non-medicated, single-use
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.
TDW5085
In Commercial Distribution

  • 08806343919113 ()


  • General surgical procedure kit, non-medicated, single-use
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.
TDW5070
In Commercial Distribution

  • 08806343919106 ()


  • General surgical procedure kit, non-medicated, single-use
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.
TDW4513
In Commercial Distribution

  • 08806343919090 ()


  • General surgical procedure kit, non-medicated, single-use
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.
TDW4511
In Commercial Distribution

  • 08806343919083 ()


  • General surgical procedure kit, non-medicated, single-use
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.
TDW4510
In Commercial Distribution

  • 08806343919076 ()


  • General surgical procedure kit, non-medicated, single-use
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.
TDW4585
In Commercial Distribution

  • 08806343919069 ()


  • General surgical procedure kit, non-medicated, single-use
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.
TDW4570
In Commercial Distribution

  • 08806343919052 ()


  • General surgical procedure kit, non-medicated, single-use
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