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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BC 60 plus, Blood Microfilter System SQ 40 S, Gas Filter
DATASCOPE CORP.
BO-T 37311
Not in Commercial Distribution

  • 00607567211384 ()
709000237

  • Cardiopulmonary bypass system blood tubing set
BO-RF32 RotaFlow,
DATASCOPE CORP.
BO-T 8040
Not in Commercial Distribution

  • 00607567210165 ()
709000323

  • Cardiopulmonary bypass system blood tubing set
Hygieia d-Nav System Phone App - Apple iOS Operating System
HYGIEIA, INC.
V1m00b054i
In Commercial Distribution

  • 00860001044201 ()


  • Calculator, programmable
iOS mobile device software for use with Eko products.
Eko Devices, Inc.
3.1.1
In Commercial Distribution

  • 00863609000334 ()


  • Medical equipment clinical data interfacing software
A digital epilepsy care management platform application for iOS.
Ai Nile Inc
Nile for iOS
In Commercial Distribution

  • 00850031821002 ()


  • Medication reminder application software
APP, Bluetooth, otoTune iOS for self-fit, app-controlled hearing aids
Soundwave Hearing, LLC
990019-SWH
In Commercial Distribution

  • 00850016231383 ()


  • Audiometric/hearing device software
US Dexcom Follow App for iOS, (mg/dL), v4
Dexcom, Inc.
SW10497
In Commercial Distribution

  • 00386270001931 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Titan Design 4.8mm Tg Hex Abutment Plastic Sleeve Non-Hex
TITAN IMPLANT INC
TN-48TGIAPSNH
In Commercial Distribution

  • 00842448112361 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Titan Design 4.8mm Tg Hex Abutment Plastic Sleeve Hex
TITAN IMPLANT INC
TN-48TGIAPSH
In Commercial Distribution

  • 00842448112354 ()


  • Dental implant suprastructure, temporary, preformed, single-use
Periodontal Surgical chisel, double-ended, modif. TG with Ochsenbein cutouts
A. TITAN INSTRUMENTS, INC.
CTG-0
In Commercial Distribution

  • 00841685109097 ()


  • Dental osteotome
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