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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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CC MsIgG2b - 15099590542030

COULTER CLONE MsIgG2b
Beckman Coulter, Inc.
6603001
In Commercial Distribution

  • 15099590542030 ()
6603001

  • Multiple CD cell marker IVD, control

CC B4-FITC - 15099590542023

COULTER CLONE B4-FITC
Beckman Coulter, Inc.
6603012
In Commercial Distribution

  • 15099590542023 ()
6603012

  • Multiple CD cell marker IVD, antibody

CC B4-RD1 - 15099590542009

COULTER CLONE B4-RD1
Beckman Coulter, Inc.
6603024
In Commercial Distribution

  • 15099590542009 ()
6603024

  • Multiple CD cell marker IVD, antibody

CC MsIgG2b-RD1 - 15099590541941

COULTER CLONE MsIgG2b-RD1
Beckman Coulter, Inc.
6603038
In Commercial Distribution

  • 15099590541941 ()
6603038

  • Multiple CD cell marker IVD, control

STERISPINE CC - 03760219913153

No Description
SAFE ORTHOPAEDICS
KITCCS10L
In Commercial Distribution

  • 03760219913153 ()


  • Metallic spinal interbody fusion cage

STERISPINE CC - 03760219913146

No Description
SAFE ORTHOPAEDICS
KITCCS09L
In Commercial Distribution

  • 03760219913146 ()


  • Metallic spinal interbody fusion cage

STERISPINE CC - 03760219913139

No Description
SAFE ORTHOPAEDICS
KITCCS08L
In Commercial Distribution

  • 03760219913139 ()


  • Metallic spinal interbody fusion cage

STERISPINE CC - 03760219913122

No Description
SAFE ORTHOPAEDICS
KITCCS07L
In Commercial Distribution

  • 03760219913122 ()


  • Metallic spinal interbody fusion cage

STERISPINE CC - 03760219913115

No Description
SAFE ORTHOPAEDICS
KITCCS06L
In Commercial Distribution

  • 03760219913115 ()


  • Metallic spinal interbody fusion cage

STERISPINE CC - 03760219913108

No Description
SAFE ORTHOPAEDICS
KITCCS05L
In Commercial Distribution

  • 03760219913108 ()


  • Metallic spinal interbody fusion cage

STERISPINE CC - 03760219913092

No Description
SAFE ORTHOPAEDICS
KITCCS08S
In Commercial Distribution

  • 03760219913092 ()


  • Metallic spinal interbody fusion cage

STERISPINE CC - 03760219913085

No Description
SAFE ORTHOPAEDICS
KITCCS07S
In Commercial Distribution

  • 03760219913085 ()


  • Metallic spinal interbody fusion cage

STERISPINE CC - 03760219913078

No Description
SAFE ORTHOPAEDICS
KITCCS06S
In Commercial Distribution

  • 03760219913078 ()


  • Metallic spinal interbody fusion cage

STERISPINE CC - 03760219913061

No Description
SAFE ORTHOPAEDICS
KITCCS05S
In Commercial Distribution

  • 03760219913061 ()


  • Metallic spinal interbody fusion cage

Persona Medical - 00851362008087

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

RXEars - 00851362008025

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

3DIEMME RealGUIDE - 08050038830003

Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software

Clarius Ultrasound Scanner - 07540205000403

No Description
Clarius Mobile Health Corp
App - Android
In Commercial Distribution

  • 07540205000403 ()
12-01-00004

  • Ultrasound imaging system application software
  • Radiological PACS software

Clarius Ultrasound Scanner - 07540205000397

No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software

DryGuardians - 07350078445160

No Description
Pjama AB
DryGuardians App
In Commercial Distribution

  • 07350078445160 ()
4200

  • Incontinence sensor/alarm

FrameLink™ - 00721902966460

SFTWR 9731128 KIT, FRAMELINK APP -PLUS
MEDTRONIC NAVIGATION, INC.
9731128
In Commercial Distribution

  • 00721902966460 ()


  • Multi-purpose stereotactic surgery system

SonoNav™ - 00721902865565

SFTWR 9730780 KIT SONONAV APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730780
In Commercial Distribution

  • 00721902865565 ()


  • Multi-purpose stereotactic surgery system

N/A - 00721902865558

SFTWR 9730897 KIT FUNCTIONAL APP - PLUS
MEDTRONIC NAVIGATION, INC.
9730897
In Commercial Distribution

  • 00721902865558 ()


  • Multi-purpose stereotactic surgery system

GN ReSound - 05708296071524

APP,RS SMART 3D,1.0,ANDR
Gn Hearing A/S
20410700
In Commercial Distribution

  • 05708296071524 ()


  • Hearing aid/implant system remote control

GN ReSound - 05708296071517

APP,RS SMART 3D,1.0,IOS
Gn Hearing A/S
20410600
In Commercial Distribution

  • 05708296071517 ()


  • Hearing aid/implant system remote control

Beltone - 05708296071500

APP,BT SMART REMOTE,1.0.6,ANDR
Gn Hearing A/S
20410000
In Commercial Distribution

  • 05708296071500 ()


  • Hearing aid/implant system remote control

Beltone - 05708296071494

APP,BT SMART REMOTE,1.0.6,IOS
Gn Hearing A/S
20409600
In Commercial Distribution

  • 05708296071494 ()


  • Hearing aid/implant system remote control

GN ReSound - 05708296071463

APP,KIRKL SIGN NAV,1.0.6,ANDR
Gn Hearing A/S
20410100
In Commercial Distribution

  • 05708296071463 ()


  • Hearing aid/implant system remote control

GN ReSound - 05708296071456

APP,KIRKL SIGN NAV,1.0.6,IOS
Gn Hearing A/S
20409700
In Commercial Distribution

  • 05708296071456 ()


  • Hearing aid/implant system remote control

N/A - 00643169855649

SW APP A610 ACTIVA CLINICIAN DBS
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00643169855649 ()


  • Multiple active implantable device programmer

N/A - 00643169834330

SW APP A521 GU PATIENT EVALUATION
MEDTRONIC, INC.
A521
In Commercial Distribution

  • 00643169834330 ()


  • Wearable peripheral nerve electrical stimulator programmer

N/A - 00643169834323

SW APP A511 GU CLINICIAN EVALUATION
MEDTRONIC, INC.
A511
In Commercial Distribution

  • 00643169834323 ()


  • Wearable peripheral nerve electrical stimulator programmer

CareLink SmartSync™ PSA Application - 00643169833753

SW D00U002 CARELINK SMARTSYNC PSA APP
MEDTRONIC, INC.
D00U002
In Commercial Distribution

  • 00643169833753 ()


  • Implantable cardiac device management application software

N/A - 00643169771048

SW APP A820 TDD PATIENT PROG
MEDTRONIC, INC.
A820
In Commercial Distribution

  • 00643169771048 ()


  • Infusion pump programmer

N/A - 00643169738065

SW APP A902 PATIENT DATA SERVICES
MEDTRONIC, INC.
A902
In Commercial Distribution

  • 00643169738065 ()


  • Multiple active implantable device programmer

Halo Systems - 05690977334960

CB RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300T
Not in Commercial Distribution

  • 05690977334960 ()
515300T

  • Cervical spine immobilization head ring

Halo Systems - 05690977326200

CB RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500T
Not in Commercial Distribution

  • 05690977326200 ()
515500T

  • Cervical spine immobilization head ring

Halo Systems - 05690977319035

CB RING KIT TI STD-No App
OSSUR AMERICAS, INC.
515400T
Not in Commercial Distribution

  • 05690977319035 ()
515400T

  • Cervical spine immobilization head ring

Halo Systems - 05690977308718

J TONG SML/MED- No App
OSSUR AMERICAS, INC.
JT-215
Not in Commercial Distribution

  • 05690977308718 ()
JT-215

  • Traction system skull tongs

Halo Systems - 05690977308664

OB RESOLVE RING KIT LG-No App
OSSUR AMERICAS, INC.
515500D
Not in Commercial Distribution

  • 05690977308664 ()
515500D

  • Cervical spine immobilization head ring
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