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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 - 62860105550028

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

  • 62860105550028 ()
  • 62860105550011 ()
10555094050

  • Nebulizing system delivery set, reusable

T-HANDLE WITH FEMALE HUDSON ADAPTOR - 00887868131653

No Description
Biomet Orthopedics, LLC
2274-32-000
In Commercial Distribution

  • 00887868131653 ()
227432000

  • Surgical instrument handle, non-torque-limiting

Armboard short with short post - 07350111830434

No Description
Reison Medical AB
10-380-KR
In Commercial Distribution

  • 07350111830434 ()


  • Arm procedure positioner, reusable

Armboard short with long post - 07350111830427

No Description
Reison Medical AB
10-380-KL
In Commercial Distribution

  • 07350111830427 ()


  • Arm procedure positioner, reusable

Profin with IPR Lamineer Tips - 07350081496746

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

PERPOS PLS Instruments with Tray - 81195401009648

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

Starling Monitor with SpO2 Module - 72900130302906

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 Cassette with EV Screens - 60889971002785

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 Cassette with EV Screens - 60889971002730

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 - 60888937022003

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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