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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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Lightweight Dual Arm
SKYTRON LLC
Ergon 3
In Commercial Distribution

  • 10841736100827 ()
100 Series

  • General utility supply system, ceiling-mounted
Tandem Mount
SKYTRON LLC
Ergon 2
In Commercial Distribution

  • 10841736100698 ()
E2 330 Series

  • General utility supply system, ceiling-mounted
Central Tandem Mount with Lightweight Arm with optional surgical lighting.
SKYTRON LLC
Ergon 2
In Commercial Distribution

  • 10841736100681 ()
E2 320 Series

  • General utility supply system, ceiling-mounted
  • Transportable medical equipment stand, non-powered
  • Operating room light system
Central Mount with optional surgical lighting.
SKYTRON LLC
Ergon 2
In Commercial Distribution

  • 10841736100674 ()
E2 310 Series

  • Transportable medical equipment stand, non-powered
  • Operating room light system
  • General utility supply system, ceiling-mounted
Dual Radial Arm Set
SKYTRON LLC
Ergon 2
In Commercial Distribution

  • 10841736100667 ()
E2 300 Series

  • General utility supply system, ceiling-mounted
Q Dual Radial Arm Set
SKYTRON LLC
Ergon 2
In Commercial Distribution

  • 10841736100650 ()
E2 200 Series

  • General utility supply system, ceiling-mounted
Lightweight Central Tandem Mount with optional surgical lighting.
SKYTRON LLC
Ergon 2
In Commercial Distribution

  • 10841736100643 ()
E2 120 Series

  • Operating room light system
  • General utility supply system, ceiling-mounted
Lightweight Central Mount with optional surgical lighting.
SKYTRON LLC
Ergon 2
In Commercial Distribution

  • 10841736100636 ()
E2 110 Series

  • Operating room light system
  • General utility supply system, ceiling-mounted
LED Surgical Light with center focus
SKYTRON LLC
Stellar XL
In Commercial Distribution

  • 10841736100148 ()


  • Transportable medical equipment stand, non-powered
  • Operating room light system
Integrity 270 Vacuum/Gravity Steam Sterilizer, 26.5"W x 37.5"H x 53"D, Power Door Lock, House Steam, Vacuum Pump
SKYTRON LLC
INTEGRITY 270VP
In Commercial Distribution

  • 10841736100131 ()
INTEGRITY 270VP

  • Steam sterilizer
LED Surgical light
SKYTRON LLC
Nautilus NL
Not in Commercial Distribution

  • 10841736100124 ()


  • Transportable medical equipment stand, non-powered
  • Operating room light system
Integrity 270 Vacuum/Gravity Steam Sterilizer, 26.5"W x 37.5"H x 53"D, Power Door Lock, Water Ejector Vacuum, House Steam
SKYTRON LLC
INTEGRITY 270
In Commercial Distribution

  • 10841736100117 ()
INTEGRITY 270

  • Steam sterilizer
Integrity 215SG Vacuum/Gravity Steam Sterilizer, 21.5"W x 21.5"H x 38"D, Vertical Power Sliding Door w/ Foot Pedal Control, Water Ejector Vacuum System, Steam Generator
SKYTRON LLC
INTEGRITY 215SG
In Commercial Distribution

  • 10841736100087 ()
INTEGRITY 215SG

  • Steam sterilizer
LED Surgical Light with center focus with optional camera capability
SKYTRON LLC
Aurora LED
Not in Commercial Distribution

  • 10841736100070 ()


  • Operating room light system
  • Transportable medical equipment stand, non-powered
Integrity 215 Vacuum/Gravity Steam Sterilizer, 21.5"W x 21.5"H x 38"D, Vertical Power Sliding Door w/ Foot Pedal Control, Water Ejector Vacuum System, House Steam
SKYTRON LLC
INTEGRITY 215
In Commercial Distribution

  • 10841736100063 ()
INTEGRITY 215

  • Steam sterilizer
Integrity 175SG Vacuum/Gravity Steam Sterilizer, 17.5"W x 17.5"H x 26.5"D, Vertical Power Sliding Door w/ Foot Pedal Control, Water Ejector Vacuum System, Steam Generator
SKYTRON LLC
INTEGRITY 175SG
In Commercial Distribution

  • 10841736100056 ()
INTEGRITY 175SG

  • Steam sterilizer
LED Surgical Light with center focus with optional camera capability
SKYTRON LLC
Aurora II
Not in Commercial Distribution

  • 10841736100049 ()


  • Operating room light system
  • Transportable medical equipment stand, non-powered
LED Surgical Light with center focus with optional camera capability
SKYTRON LLC
Aurora 3
Not in Commercial Distribution

  • 10841736100032 ()


  • Transportable medical equipment stand, non-powered
  • Operating room light system
LED Surgical Light with center focus with optional camera capability
SKYTRON LLC
Aurora Four
In Commercial Distribution

  • 10841736100025 ()


  • Operating room light system
  • Transportable medical equipment stand, non-powered
Integrity 175 Vacuum/Gravity Steam Sterilizer, 17.5"W x 17.5"H x 26.5"D, Vertical Power Sliding Door w/ Foot Pedal Control, Water Ejector Vacuum System, House Steam, 120 Volt
SKYTRON LLC
INTEGRITY 175
In Commercial Distribution

  • 10841736100018 ()
INTEGRITY 175

  • Steam sterilizer
Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8813C
Not in Commercial Distribution

  • 17958909771661 ()
  • 07958909771664 ()


  • Infrared patient thermometer, skin
Nasal Wash. Nose drug administration device intended specifically to administer medicinal substances or saline solutions to treat nose
FLAEM NUOVA SPA
P0709EM
In Commercial Distribution

  • 08018294012793 ()
DR12P00

  • Nasal irrigation set, home-use
The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas
MICRO-X LIMITED
Rover
In Commercial Distribution

  • 00935712300004 ()
MXU-RV01

  • Mobile basic diagnostic x-ray system, digital
DirectLink™ ICP Module
Integra LifeSciences Switzerland Sàrl
826828
In Commercial Distribution

82-6828

  • Intracranial pressure monitor
LT Retractor, 90mm, Teeth
STRYKER CORPORATION
C90T
In Commercial Distribution

  • 00816728020738 ()
C90T

  • Fibreoptic retractor handle
The PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during surgical procedures. It is intended to be used with a variety of standard commercially available electrosurgical units.
STRYKER CORPORATION
PB1
In Commercial Distribution

  • 00816728020158 ()
PB1

  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
The PhotonBlade with Adaptive Smoke Evacuation is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
STRYKER CORPORATION
PB2SE
In Commercial Distribution

  • 00816728021261 ()
PB2SE

  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
No Description
ORTHOSENSOR INC
VERASENSE for Smith & Nephew Legion PS size 3-4
Not in Commercial Distribution

  • 00816818021720 ()
SNN-LGNPS34

  • Arthroplasty force sensor
No Description
ORTHOSENSOR INC
VERASENSE for Smith & Nephew Legion PS size 1-2
Not in Commercial Distribution

  • 00816818021713 ()
SNN-LGNPS12

  • Arthroplasty force sensor
No Description
ORTHOSENSOR INC
VERASENSE for Smith & Nephew Legion CR size 7-8
Not in Commercial Distribution

  • 00816818021706 ()
SNN-LGNCR78

  • Arthroplasty force sensor
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