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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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Galaxy - 08809263396057

Galaxy ACIF cage H5 x W15 x L14
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263396057 ()

  • Width 15mm, Length 14mm
  • Height: 5 Millimeter
NC551514

  • Bone-screw internal spinal fixation system, non-sterile

Galaxy - 08809263396002

Galaxy ACIF cage H5 x W14 x L12
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809263396002 ()

  • Height: 5 Millimeter
  • Width 14mm, Length 12mm
NC551412

  • Bone-screw internal spinal fixation system, non-sterile

MONET - 00841732165168

ACIF Depth Stop Trial, MD, 12°, H5/H6mm
CTL Medical Corporation
113.7475
In Commercial Distribution

  • 00841732165168 ()


  • Metallic spinal interbody fusion cage

MONET - 00841732165137

ACIF Depth Stop Trial, SM, 12°, H5/H6mm
CTL Medical Corporation
113.7465
In Commercial Distribution

  • 00841732165137 ()


  • Metallic spinal interbody fusion cage

MONET - 00841732129115

ACIF Depth Stop Trial, SM, Lordotic, H5/H6mm
CTL Medical Corporation
113.7415
In Commercial Distribution

  • 00841732129115 ()


  • Spinal implant trial

MONET - 00841732125483

ACIF Depth Stop Trial, MD, Parallel, H5/H6
CTL Medical Corporation
113.7425
In Commercial Distribution

  • 00841732125483 ()


  • Spinal implant trial

MONET - 00841732125452

ACIF Depth Stop Trial, SM, Parallel, H5/H6mm
CTL Medical Corporation
113.7405
In Commercial Distribution

  • 00841732125452 ()


  • Spinal implant trial

CARDINAL HEALTH - 10888439303599

ALLENTOWN LAP CHOLE APP
Cardinal Health 200, LLC
SLC11LLSL1
In Commercial Distribution

  • 50888439303597 ()
  • 10888439303599 ()
SLC11LLSL1

  • Laparoscopic surgical procedure kit, non-medicated, single-use

Medline - 10080196403998

PUMP,REPLACEMENT,APP,AIRONE
MEDLINE INDUSTRIES, INC.
MSCAOPUMP
In Commercial Distribution

  • 10080196403998 ()
MSCAOPUMP

  • Alternating-pressure inflator

OvuSense - 05060508530114

OvuSense 2 App - Android
VIO HEALTHTECH LIMITED
M032 Android
In Commercial Distribution

  • 05060508530114 ()


  • Thermometric fertility analyser

Sony - 05714880189308

Sony | Hearing Control App
Ws Audiology Usa, Inc.
Sony | Hearing Control
In Commercial Distribution

  • 05714880189308 ()
21022296

  • Audiometric/hearing device software

Bionic Circle App, Android - 00850050080176

Bionic Circle App, Android
Beta Bionics, Inc.
BOM000083
In Commercial Distribution

  • 00850050080176 ()
BB5002

  • Ambulatory insulin infusion pump software, data-display

Widex - 05706069702965

Widex ToneLink App Android
Widex A/S
ToneLink app
In Commercial Distribution

  • 05706069702965 ()
5 300 0017 001

  • Hearing aid enhanced audio device, telecommunication/multimedia

Widex - 05706069689112

Beyond App Android 1.2
Widex A/S
BEYOND app
In Commercial Distribution

  • 05706069689112 ()
5 300 0009 001

  • Hearing aid/implant system remote control

Widex - 05706069930320

Widex MOMENT App Android
Widex A/S
Moment app
In Commercial Distribution

  • 05706069930320 ()
5 300 0022 001

  • Hearing aid enhanced audio device, telecommunication/multimedia

Oticon - 05707131328526

ON APP 1.2 ANDROID
Oticon A/S
176635
In Commercial Distribution

  • 05707131328526 ()


  • Hearing aid/implant system remote control

TempTraq® - 00851203006432

TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006432 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq® - 00851203006388

TempTraq Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006388 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq® - 00851203006364

TempTraq Patient Android App
BLUE SPARK TECHNOLOGIES, INC.
4.x.x
In Commercial Distribution

  • 00851203006364 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq® - 00851203006173

TempTraq Clinician Web App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician Web App
Not in Commercial Distribution

  • 00851203006173 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq® - 00851203006128

TempTraq Clinician Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Clinician Android App
Not in Commercial Distribution

  • 00851203006128 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq® - 00851203006111

TempTraq Patient Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Patient Android App
Not in Commercial Distribution

  • 00851203006111 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

TempTraq - 00851203006036

TempTraq Consumer Android App
BLUE SPARK TECHNOLOGIES, INC.
TempTraq Consumer Android App
Not in Commercial Distribution

  • 00851203006036 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

Sirona - 00851074007149

Sirona B Android App
DATRIX LLC
RX22711
In Commercial Distribution

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder

Sirona - 00851074007125

Sirona B PC App
DATRIX LLC
RX22673
In Commercial Distribution

  • 00851074007125 ()


  • Telemetric electrocardiographic ambulatory recorder

Bernafon - 05714464058921

Bernafon App 1.0.0 Android
Sbo Hearing A/S
242481
In Commercial Distribution

  • 05714464058921 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464146017

BERNAFON APP 1.5.0 ANDROID
Sbo Hearing A/S
274910
In Commercial Distribution

  • 05714464146017 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464139484

BERNAFON APP 1.4.0 ANDROID
Sbo Hearing A/S
270494
In Commercial Distribution

  • 05714464139484 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464133918

BERNAFON APP 1.3.0 ANDROID
Sbo Hearing A/S
269351
In Commercial Distribution

  • 05714464133918 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464127221

BERNAFON APP 1.2.0 ANDROID
Sbo Hearing A/S
265713
In Commercial Distribution

  • 05714464127221 ()


  • Hearing aid/implant system remote control

Bernafon - 05714464125159

BERNAFON APP 1.1.0 ANDROID
Sbo Hearing A/S
264781
In Commercial Distribution

  • 05714464125159 ()


  • Hearing aid/implant system remote control

VEA - 00190376470351

Vea - Mobile Alignment App
ALPHATEC SPINE, INC.
AIX21000
In Commercial Distribution

  • 00190376470351 ()


  • Orthopaedic/craniofacial implantation planning software

Omnipod 5 Controller APP - 10385083000565

Omnipod 5 Controller APP
Insulet Corporation
M009-3P-AP
In Commercial Distribution

  • 10385083000565 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

Omnipod 5 Controller APP - 10385083000336

Omnipod 5 Controller APP
Insulet Corporation
M009-S-AP
In Commercial Distribution

  • 10385083000336 ()


  • Ambulatory insulin infusion pump/interstitial glucose monitoring system

PRC-Saltillo - 00816486021367

TC Discover App UDID
PRENTKE ROMICH COMPANY
Discover App
In Commercial Distribution

  • 00816486021367 ()
19285-9

  • Voice synthesizer/digitizer

Panacea - 00092237617946

DS Replacement APP Pump,
COMPASS HEALTH BRANDS CORP.
DS-NADJP
In Commercial Distribution

  • 30092237617947 ()
  • 00092237617946 ()


  • Alternating-pressure inflator

CIONIC - G345620000040

CIONIC Android Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000040 ()
62000004

  • Gait-enhancement electrical stimulation system, external

Perifit - 03770014642660

Kegel Exerciser with App
X6 INNOVATIONS
Green Perifit
In Commercial Distribution

  • 03770014642660 ()


  • Pelvic floor muscle exerciser

Perifit - 03770014642448

Kegel Exerciser with App
X6 INNOVATIONS
Pink Perifit
In Commercial Distribution

  • 03770014642448 ()


  • Pelvic floor muscle exerciser

Perifit Care+ - 03770014642196

Kegel Exerciser with App
X6 INNOVATIONS
Purple Perifit Care+
In Commercial Distribution

  • 03770014642196 ()


  • Pelvic floor muscle exerciser

Perifit Care - 03770014642165

Kegel Exerciser with App
X6 INNOVATIONS
Green Perifit Care
In Commercial Distribution

  • 03770014642165 ()


  • Pelvic floor muscle exerciser

Perifit Care - 03770014642134

Kegel Exerciser with App
X6 INNOVATIONS
Pink Perifit Care
In Commercial Distribution

  • 03770014642134 ()


  • Pelvic floor muscle exerciser

Cochlear - 09321502046145

Osia Smart App (Android)
COCHLEAR LIMITED
P1340354
In Commercial Distribution

  • 09321502046145 ()
P1340354

  • Audiometric/hearing device software

Baha - 09321502034180

Baha 5 Smart App
Cochlear Bone Anchored Solutions AB
P736025
Not in Commercial Distribution

  • 09321502034180 ()
P736025

  • Hearing aid/implant system remote control

Baha - 09321502034159

Baha 5 Smart App
Cochlear Bone Anchored Solutions AB
95448
Not in Commercial Distribution

  • 09321502034159 ()
95448

  • Hearing aid/implant system remote control

Meridian Medical - 00815067042562

BARIATRIC APP PAD ONLY
COMPASS HEALTH BRANDS CORP.
1105
In Commercial Distribution

  • 30815067042563 ()
  • 00815067042562 ()


  • Alternating-pressure bed mattress overlay, reusable

Meridian Medical - 00815067040162

APP SYSTEM AIR ADJUSTABLE
COMPASS HEALTH BRANDS CORP.
1003
In Commercial Distribution

  • 30815067040163 ()
  • 00815067040162 ()


  • Alternating-pressure bed mattress overlay system

HANSATON - 07613389127225

HANSATON Stream Remote App
Hansaton Akustik GmbH
088-5003
In Commercial Distribution

  • 07613389127225 ()
088-5003

  • Audiometric/hearing device software

UNITRON - 07613389075823

Unitron Remote Plus app
Unitron Hearing Division
088-5001
In Commercial Distribution

  • 07613389075823 ()
088-5001

  • Audiometric/hearing device software

All-Day Clear 1.0 app - 07613389557930

All-Day Clear 1.0 app
Sonova AG
088-5015
In Commercial Distribution

  • 07613389557930 ()
088-5015

  • Audiometric/hearing device software
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