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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Sunglasses
Colors In Optics, Ltd.
COLORS CS368 - WHITE
In Commercial Distribution

  • 00781268839235 ()
CS368 WHI

  • Tinted non-prescription spectacles
ard plastic tip saliva ejectors are just that-hard! They pinch lingual surfaces, jab the mandible and aspirate tender tissue. Here is a truly comfortable solution-so comfortable, it's patented! Total-Comfort Soft Tip Aspirators feature cushioned, flexible, patient-friendly tips. Tested and proven to be gentle on soft tissue and bone while reducing soft tissue aspiration. Elastic tips are securely bonded for safety. 100% non-latex. 6" long. 100 aspirators per bag with white or clear tubing.
PRACTICON, INC.
K2900-BTS155TC
Not in Commercial Distribution

  • 00723896009901 ()
  • 00723896009895 ()
  • 00723896001257 ()
70-24911 WHI

  • Dental suction system cannula, single-use
Hard plastic tip saliva ejectors are just that-hard! They pinch lingual surfaces, jab the mandible and aspirate tender tissue. Here is a truly comfortable solution-so comfortable, it's patented! Total-Comfort Soft Tip Aspirators feature cushioned, flexible, patient-friendly tips. Tested and proven to be gentle on soft tissue and bone while reducing soft tissue aspiration. Elastic tips are securely bonded for safety. 100% non-latex. 6" long. 100 aspirators per bag with white or clear tubing.
PRACTICON, INC.
K2900-BAS155TC
Not in Commercial Distribution

  • 00723896009864 ()
  • 00723896009857 ()
  • 00723896001165 ()
70-24910 WHI

  • Dental suction system cannula, single-use
IOS & Android based APP used to control Evok 1600 OTE/BTE device.
Persona Medical
Persona APP
In Commercial Distribution

  • 00851362008087 ()


  • Air-conduction hearing aid, behind-the-ear
IOS & Android based APP used to control RxEars RX7 BTE device.
Persona Medical
RxEars APP
In Commercial Distribution

  • 00851362008025 ()


  • Air-conduction hearing aid, behind-the-ear
No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software
No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software
Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software
No Description
Pjama AB
DryGuardians App
In Commercial Distribution

  • 07350078445160 ()
4200

  • Incontinence sensor/alarm
OXIMETER,PULSE,FINGER,BLUETOOTH WITH APP
MEDLINE INDUSTRIES, INC.
HCSM70T
In Commercial Distribution

  • 00193489094261 ()
HCSM70T

  • Vacuum suction regulator/regulation set, general-purpose
Cycle Tracking iPhone App (Version 4.0)
APPLE INC.
Feature Version 4.x
In Commercial Distribution

  • 00194253312529 ()


  • Menstrual cycle self-monitoring software
Cycle Tracking Watch App (Version 4.0)
APPLE INC.
Feature Version 4.x
In Commercial Distribution

  • 00194253312512 ()


  • Menstrual cycle self-monitoring software
Cycle Tracking iPhone App (Version 3.0)
APPLE INC.
Feature Version 3.x
In Commercial Distribution

  • 00194252845974 ()


  • Menstrual cycle self-monitoring software
Cycle Tracking Watch App (Version 3.0)
APPLE INC.
Feature Version 3.x
In Commercial Distribution

  • 00194252845967 ()


  • Menstrual cycle self-monitoring software
Atrial Fibrillation History Feature Watch app
APPLE INC.
Feature version 1.x
In Commercial Distribution

  • 00194252456804 ()


  • Self-care monitoring/reporting software
Atrial Fibrillation History Feature iPhone app
APPLE INC.
Feature version 1.x
In Commercial Distribution

  • 00194252456798 ()


  • Self-care monitoring/reporting software
Cochlear Baha Control App for Android
Cochlear Bone Anchored Solutions AB
95460
In Commercial Distribution

  • 09321502036399 ()
95460

  • Hearing aid/implant system remote control
Cochlear Baha Control App for iOS
Cochlear Bone Anchored Solutions AB
95459
In Commercial Distribution

  • 09321502036382 ()
95459

  • Hearing aid/implant system remote control
IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYNDV2325
In Commercial Distribution

  • 20193489194811 ()
  • 10193489194814 ()
DYNDV2325

  • Peripheral intravenous catheterization support kit
MAJ-1352 BALLOON APP. FOR EBUS BRONCHSCP
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1352
In Commercial Distribution

  • 04953170355981 ()


  • Surgical instrument assist arm system, manually-adjusted
PAD,REPLACEMENT,APP,W/FLAPS,AIRONE
MEDLINE INDUSTRIES, INC.
MSC80710
In Commercial Distribution

  • 10080196669943 ()
MSC80710

  • Alternating-pressure inflator
IV START KIT W/CHLORAPREP APP
MEDLINE INDUSTRIES, INC.
DYND74260
In Commercial Distribution

  • 10080196992980 ()
  • 40080196992981 ()
DYND74260

  • General surgical procedure kit, non-medicated, single-use
APP,RS SMART 3D,1.0,ANDR
Gn Hearing A/S
20410700
In Commercial Distribution

  • 05708296071524 ()


  • Hearing aid/implant system remote control
APP,RS SMART 3D,1.0,IOS
Gn Hearing A/S
20410600
In Commercial Distribution

  • 05708296071517 ()


  • Hearing aid/implant system remote control
APP,BT SMART REMOTE,1.0.6,ANDR
Gn Hearing A/S
20410000
In Commercial Distribution

  • 05708296071500 ()


  • Hearing aid/implant system remote control
APP,BT SMART REMOTE,1.0.6,IOS
Gn Hearing A/S
20409600
In Commercial Distribution

  • 05708296071494 ()


  • Hearing aid/implant system remote control
APP,KIRKL SIGN NAV,1.0.6,ANDR
Gn Hearing A/S
20410100
In Commercial Distribution

  • 05708296071463 ()


  • Hearing aid/implant system remote control
APP,KIRKL SIGN NAV,1.0.6,IOS
Gn Hearing A/S
20409700
In Commercial Distribution

  • 05708296071456 ()


  • Hearing aid/implant system remote control
SW APP A902 PATIENT DATA SERVICES
MEDTRONIC, INC.
A902
In Commercial Distribution

  • 00643169738065 ()


  • Multiple active implantable device programmer
Bluetooth Basal Thermometer with Ovy App
BEURER NORTH AMERICA, L.P.
OT30
In Commercial Distribution

  • 00850003500560 ()
791.77

  • Thermometric fertility analyser
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