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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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Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69442
In Commercial Distribution

  • 00842430100604 ()
69442

  • Operating table mattress, basic
No Description
Axiodent Inc.
28019
In Commercial Distribution

  • D161280190 ()


  • Denture trial fabrication wax
This is a medical device.
KaVo Dental GmbH
0.571.5621
In Commercial Distribution

  • EKAV057156210 ()
rootplaner Tip No 24

  • Ultrasonic dental scaling/debridement system
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
5844-17
In Commercial Distribution

  • 00842430104374 ()
  • 00842430111860 ()
5844-17

  • Medical equipment/instrument drape, single-use
A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device.
NOVOSCI CORP.
301124-000
In Commercial Distribution

  • B0663011240000 ()
  • B0663011240006 ()
301124-000

  • Cardiopulmonary bypass system priming set
Neurofeedback headbox
DEYMED Diagnostic s.r.o.
43-139
In Commercial Distribution

  • 08592566431395 ()
43-139

  • Psychophysiological biofeedback system
PureCeption 24 - Determination Bi-Layer Kit. 6x12 mL each of 40% UPPER and 80% LOWER Phase In HEPES-buffered HTF
Origio A/S
ART-2024
In Commercial Distribution

  • 60888937818583 ()


  • IVF medium kit
Ocean Ergo XL Dir. Lock
INVACARE CORPORATION
1603080
In Commercial Distribution

  • 04028698132564 ()

  • 1
1603080, 1603157

  • Shower seat, non-powered
No Description
ACCUTRON, INC.
26433-FRU
In Commercial Distribution

  • 00813830026177 ()
26433-FRU

  • Medical gas pipeline system
No Description
ACCUTRON, INC.
33015-9
In Commercial Distribution

  • 00813830025699 ()
33015-9

  • Anaesthesia face mask, single-use
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