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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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MY TSF HOMECARE APP iOS
Smith & Nephew, Inc.
71075402
In Commercial Distribution

  • 00885556746387 ()
71075402

  • Wireless patient monitor/sensor reporting software, layperson-use
ALLENTOWN LAP CHOLE APP PACK
Cardinal Health 200, LLC
SBA11LLSL8
In Commercial Distribution

  • 50198956020595 ()
  • 10198956020597 ()
SBA11LLSL8

  • Laparoscopic surgical procedure kit, non-medicated, single-use
SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00643169491748 ()


  • ENT stereotactic surgery system
SOFTWARE 9733467 FUSION ENT APP
MEDTRONIC NAVIGATION, INC.
9733467
In Commercial Distribution

  • 00613994377517 ()


  • ENT stereotactic surgery system
G7 Wear OS Watch App
Dexcom, Inc.
SW14502
In Commercial Distribution

  • 00386270005175 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Lingo Biosensor iOS App US
ABBOTT DIABETES CARE INC
78783-01
In Commercial Distribution

  • 00357599849009 ()
78783-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Combo Cartridge, 10pk.
Lifehealth
049330
In Commercial Distribution

  • 00856522006118 ()
  • 00085622006125 ()
039903-10

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
CC Cartridge, 25 count
Lifehealth
049330
In Commercial Distribution

  • 00856522006002 ()
  • 00856522006125 ()
039903

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
Colado CC 1oz./31 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
627533AN
Not in Commercial Distribution

  • DIVO627533AN1 ()
627533AN

  • Dental casting non-noble alloy
Colado CC 250 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
627532AN
Not in Commercial Distribution

  • DIVO627532AN1 ()
627532AN

  • Dental casting non-noble alloy
Colado CC 1000 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
627531AN
Not in Commercial Distribution

  • DIVO627531AN1 ()
627531AN

  • Dental casting non-noble alloy
Colado CC 25 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
627530AN
Not in Commercial Distribution

  • DIVO627530AN1 ()
627530AN

  • Dental casting non-noble alloy
inCoris CC maxi L 1 Stck.
SIRONA Dental Systems GmbH
6339613
Not in Commercial Distribution

  • E27663396132 ()


  • Dental casting non-noble alloy
inCoris CC maxi S 1 Stck
SIRONA Dental Systems GmbH
6339597
Not in Commercial Distribution

  • E27663395972 ()


  • Dental casting non-noble alloy
inCoris CC medi 5 Stck.
SIRONA Dental Systems GmbH
6339571
In Commercial Distribution

  • E27663395712 ()
  • E27663633160 ()


  • Dental casting non-noble alloy
inCoris CC mono 10 Stck.
SIRONA Dental Systems GmbH
6339555
Not in Commercial Distribution

  • E27663395552 ()
  • E27663395300 ()


  • Dental casting non-noble alloy
The Narval CC mandibular repositioning device is a removable intraoral device used for the treatment of snoring and Obstructive Sleep Apnea (OSA). Similarly to other mandibular repositioning device, the Narval CC functions by advancing the lower jaw (mandible) in a forward position during sleep. This acts to increase the patient's pharyngeal space, improving their ability to exchange air and reducing their tendency to snore.
RESMED SA
200002
In Commercial Distribution

  • 03760287780022 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
No Description
SAFE ORTHOPAEDICS
KITCCANC
In Commercial Distribution

  • 03760219913054 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use
TRULIANT 10 MM LONG IM PILOT DRILL WITH TROCAR TIP
Exactech, Inc.
02-019-30-0100
In Commercial Distribution

  • 10885862630186 ()
02-019-30-0100

  • Bone-resection orthopaedic reamer, reusable
TRULIANT STEM EXT TRIAL15MM X 120MM
Exactech, Inc.
02-013-60-1512
In Commercial Distribution

  • 10885862629852 ()
02-013-60-1512

  • Knee femur prosthesis trial, reusable
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