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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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MC 300 Nebulizer with Mouthpiece
Trudell Medical International
105550
Not in Commercial Distribution

  • 62860105550028 ()
  • 62860105550011 ()
10555094050

  • Nebulizing system delivery set, reusable
No Description
Biomet Orthopedics, LLC
2274-32-000
In Commercial Distribution

  • 00887868131653 ()
227432000

  • Surgical instrument handle, non-torque-limiting
No Description
Reison Medical AB
10-380-KR
In Commercial Distribution

  • 07350111830434 ()


  • Arm procedure positioner, reusable
No Description
Reison Medical AB
10-380-KL
In Commercial Distribution

  • 07350111830427 ()


  • Arm procedure positioner, reusable
Profin PDX Reciprocating Contra/Angle E-Type with 5x Assorted Inter-Proximal Reduction Lamineer Tips 1 of each of the following: 0.1mm Blade Thickness, Double Sided 15 Micron Diamond Coating 0.2mm Blade Thickness, Double Sided 40 Micron Diamond Coating 0.3mm Blade Thickness, Double Sided 50 Micron Diamond Coating 0.4mm Blade Thickness, Double Sided 50 Micron Diamond Coating 0.5mm Blade Thickness, Double Sided 50 Micron Diamond Coating
Dentatus AB
PDX-P/SK2
In Commercial Distribution

  • 07350081496746 ()
PDX-P/SK2

  • Dental surgical power tool motorized handpiece/set, electric
  • Interproximal reduction kit
Instrument kit contains quantity of 1 each: Perpos 2 in 1 Drill, Perpos K-Wire, Perpos Pull Pin Remover, Perpos Tap, Perpos Device Driver, Perpos Compression Tool, Tray Assembly
INTERVENTIONAL SPINE, INC
9039-02
Not in Commercial Distribution

  • 81195401009648 ()
9039-02

  • Orthopaedic surgical procedure kit, non-medicated, reusable
A portable, non-invasive cardiac output (CO) monitoring device with SpO2 module.
CHEETAH MEDICAL (ISRAEL) LTD
CMMST5S
Not in Commercial Distribution

  • 72900130302906 ()
CMMST5S

  • Multiple vital physiological parameter monitoring system, clinical
Extraoral Cass w/ EV SCR 8x10in
CARESTREAM HEALTH, INC.
Extraoral Cassette with EV Screens
In Commercial Distribution

  • 60889971002785 ()
1002781

  • X-ray film cassette, automatic film changing
  • X-ray intensifying screen
Extraoral Cass w/ EV SCR 15x30cm
CARESTREAM HEALTH, INC.
Extraoral Cassette with EV Screens
In Commercial Distribution

  • 60889971002730 ()
1002732

  • X-ray intensifying screen
  • X-ray film cassette, automatic film changing
Endosee Advance Cannula with Pipet - 1 Kit - Contains - 1 Cannula and 1 Pipet Curet Endometrial Suction Curette 3mm OD
Coopersurgical, Inc.
ESPX5
In Commercial Distribution

  • 20888937022005 ()
  • 60888937022003 ()


  • Intrauterine cannula, single-use
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