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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Arctic Sun® Temperature Management System, Service Kit Model 5000
Medivance, Inc.
77100
In Commercial Distribution

  • 00801741080487 ()
77100

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® 5000 Control Panel Screen Protector
Medivance, Inc.
75300
In Commercial Distribution

  • 00801741080470 ()
75300

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Patient Temperature Simulator
Medivance, Inc.
74800
In Commercial Distribution

  • 00801741080449 ()
74800

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Calibration Test Unit
Medivance, Inc.
74100
In Commercial Distribution

  • 00801741080418 ()
74100

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Cleaning Solution
Medivance, Inc.
73905
In Commercial Distribution

  • 00801741080401 ()
73905

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Out Cable Philips
Medivance, Inc.
73556
In Commercial Distribution

  • 00801741080388 ()
73556

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System Assy, Cable, Temp Out, Phono Plug GE
Medivance, Inc.
73555
In Commercial Distribution

  • 00801741080371 ()
73555

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Out Cable Rusch
Medivance, Inc.
73554
In Commercial Distribution

  • 00801741080364 ()
73554

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temp Out Cable, Bard/Lemo Connector
Medivance, Inc.
73553
In Commercial Distribution

  • 00801741080357 ()
73553

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temp Out Cable, Simms/Lemo Connector
Medivance, Inc.
73552
In Commercial Distribution

  • 00801741080340 ()
73552

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Cable Philips
Medivance, Inc.
73506
In Commercial Distribution

  • 00801741080333 ()
73506

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Cable Phono
Medivance, Inc.
73505
In Commercial Distribution

  • 00801741080326 ()
73505

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Cable Rusch
Medivance, Inc.
73504
In Commercial Distribution

  • 00801741080319 ()
73504

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Cable Bard
Medivance, Inc.
73503
In Commercial Distribution

  • 00801741080302 ()
73503

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Cable Nellcor
Medivance, Inc.
73502
In Commercial Distribution

  • 00801741080296 ()
73502

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Strap Kit, Fluid Delivery Line
Medivance, Inc.
73490
In Commercial Distribution

  • 00801741080289 ()
73490

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Fluid Delivery Lines
Medivance, Inc.
73408
In Commercial Distribution

  • 00801741080272 ()
73408

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Fluid Delivery Lines
Medivance, Inc.
73407
In Commercial Distribution

  • 00801741080265 ()
73407

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Power Cord
Medivance, Inc.
73300
In Commercial Distribution

  • 00801741080258 ()
73300

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Drain Tube
Medivance, Inc.
71900
In Commercial Distribution

  • 00801741080203 ()
71900

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Fill Tube
Medivance, Inc.
71800
In Commercial Distribution

  • 00801741080197 ()
71800

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Drain Bag
Medivance, Inc.
70905
In Commercial Distribution

  • 00801741080180 ()
70905

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Shunt Line
Medivance, Inc.
70904
In Commercial Distribution

  • 00801741080173 ()
70904

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® 5000
Medivance, Inc.
50000000L
In Commercial Distribution

  • 00801741080159 ()
50000000L

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® 5000
Medivance, Inc.
50000000
In Commercial Distribution

  • 00801741080142 ()
50000000

  • 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
The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fine lines and wrinkles and increase in circulation within the perioral region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
ZC-05
In Commercial Distribution

  • 00655729008426 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
B&M SRL MARKETING NEL BENESSERE
T-SHAPE 2
In Commercial Distribution

  • 08053782383283 ()


  • Multi-modality skin/body contouring system
Omnilux Men's Facemask Device (Red & NIR).
I-SMART DEVELOPMENTS LIMITED
TN2227
In Commercial Distribution

  • 05060534510524 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
Therabody, Inc.
RecoveryTherm Hot/Cold/Vibration Knee
In Commercial Distribution

  • 00810036059732 ()


  • Hand-held electric massager
  • Electric pad localized-body heating system
  • Hot/cold therapy pack, reusable
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.
FMW
In Commercial Distribution

  • 08806343919366 ()


  • 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.
FMR
In Commercial Distribution

  • 08806343919359 ()


  • 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.
ASS
In Commercial Distribution

  • 08806343919335 ()


  • 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.
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.
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.
NMDR
In Commercial Distribution

  • 08806343919250 ()


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