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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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Invenia ABUS Prime
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
ABUS R2.5 Prime
In Commercial Distribution

  • 00195278756138 ()
H5023S2-H5013S2

  • General-purpose ultrasound imaging system
GONIOMETER
FX SOLUTIONS
902-0002
In Commercial Distribution

  • 03701037305577 ()
902-0002

  • Manual goniometer
  • Orthopaedic surgical procedure kit, non-medicated, reusable
OBALON® Inflation Can - component to inflate the OBALON® Balloon System
ReShape Lifesciences Inc.
8200-0001
Not in Commercial Distribution

  • 10859810006217 ()
  • 00859810006210 ()


  • Appetite-suppression gastric balloon inflation gas cartridge
OBALON® EzFill™ Can - component to inflate the OBALON® Balloon System
ReShape Lifesciences Inc.
8200-0001
Not in Commercial Distribution

  • 10859810006019 ()
  • 00859810006012 ()


  • Appetite-suppression gastric balloon
Automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.
Fresenius Kabi AG
6R4580R
In Commercial Distribution

  • 04086000100137 ()
6R4580R

  • Apheresis system
Automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.
Fresenius Kabi AG
6R4580
In Commercial Distribution

  • 04086000100120 ()
6R4580

  • Apheresis system
Covex Sterile X-Ray Cassette Cover: 24" x 24"
Coulmed Products Group LLC
DI-5503
In Commercial Distribution

  • 30810087350100 ()
  • 10810087350106 ()
DI-5503

  • Medical equipment/instrument drape, single-use
24" DRYER, MED. GRAPHICS 24" DRYER, MED. GRAPHICS
PERMA PURE LLC
ME Series
In Commercial Distribution

  • 00840106901821 ()
  • 00840106901784 ()
  • 00840106901814 ()
  • 00840106901807 ()
  • 00840106901791 ()
ME-050-03-99

  • Gas-sampling/monitoring respiratory tubing, single-use
24 X 24 2 PLY DRAPE T180 MIST
Encompass Group, L.L.C.
CD0033
In Commercial Distribution

  • 50609953925986 ()
  • 00609953925981 ()


  • Patient surgical drape, reusable
Base Mold 24 x 24 x 5 mm
SAKURA FINETEK U.S.A., INC.
4163
In Commercial Distribution

  • 00615233078100 ()
4163

  • Tissue embedding mould IVD, reusable
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