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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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Shrill® - 04250337118763

joimax® Shrill® Deflector Shaft Kit 2, WL 265 mm
Joimax GmbH
JSBDSK2-265
In Commercial Distribution

  • 04250337118763 ()

  • Deflector Shaft 2, Tray with cover
JSBDSK2-265

  • Arthroscopic shaver system, electrically-powered

Shrill® - 04250337115939

joimax® Shrill® Deflector Shaft Kit 2, WL 320 mm
Joimax GmbH
JSBDSK
In Commercial Distribution

  • 04250337115939 ()

  • Deflector Shaft 2, Tray with cover
JSBDSK

  • Arthroscopic shaver system, electrically-powered

iLESSYS® - 04250337115267

Scope Working Tube Distance Ring iLESSYS® Delta
Joimax GmbH
SWTDR1009
In Commercial Distribution

  • 04250337115267 ()

  • for Endoscopes with OD 10 mm
SWTDR1009

  • Spinal endoscopic-access system

C-Camsource® - 04250337105190

Camera Head C-Camsource® HD Twister (PAL)
Joimax GmbH
CSCHDC80P
In Commercial Distribution

  • 04250337105190 ()

  • single cable technology with integrated focus
CSCHDC80P

  • Endoscopic video image processing/light source system

GSO ACP1 Spinal System - M9935097310

Palm Handle with AO Quick Connect
UNIFIED SPINE, LLC
509731
In Commercial Distribution

  • M9935097310 ()

  • Palm Handle with AO Quick Connect


  • Surgical instrument handle, torque-limiting

OxyMask™ - 10620974001369

OxyMulti Kid Ultra Kit with Nebulizer
Southmedic Incorporated
OKMK-4025-8
Not in Commercial Distribution

  • 10620974001369 ()
  • 00620974001362 ()

  • OxyMulti Kid Ultra Kit with Nebulizer
OKMK-4025-8

  • Vortex oxygen face mask

OxyMulti-Mask™ - 10620974000607

OxyPlus High Humidity Kit with Nebulizer
Southmedic Incorporated
OPMK-4025-8
In Commercial Distribution

  • 10620974000607 ()
  • 00620974000600 ()

  • OxyPlus High Humidity Kit with Nebulizer
OPMK-4025-8

  • Vortex oxygen face mask

OxyMulti-Mask™ - 10620974000560

OxyMulti Mask High Humidity with nebulizer
Southmedic Incorporated
OMMK-4025-8
In Commercial Distribution

  • 10620974000560 ()
  • 00620974000563 ()

  • OxyMulti Mask High Humidity with nebulizer
OMMK-4025-8

  • Vortex oxygen face mask

OxyMask™ - 10620974000287

OxyMask CO2 with oxygen Tubing 14ft
Southmedic Incorporated
OM-2125-14
In Commercial Distribution

  • 10620974000287 ()
  • 00620974000280 ()

  • OxyMask CO2 with oxygen Tubing 14ft
OM-2125-14

  • Breathing circuit gas-sampling/monitoring set

MEDENTiKA - EMKAB91009

MedentiCAD wax-up base
MEDENTiKA GmbH
B 9100
In Commercial Distribution

  • 04251574806338 ()
  • EMKAB91009 ()

  • compatible with Bredent Medical / SKY®*
B 9100

  • Dental implant suprastructure, temporary, preformed, reusable
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