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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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MiniMed™ Mobile - 00763000827786

SFTWR MMT-6101 AHCL 2.1.0 APP ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000827786 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000968175

SFTWR MMT-6102 AHCL APP 2.7 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000968175 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000968168

SFTWR MMT-6101 AHCL APP 2.7 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000968168 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000943264

SFTWR MMT-6102 AHCL APP 2.6 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000943264 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000943257

SFTWR MMT-6101 AHCL APP 2.6 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000943257 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000910150

SFTWR MMT-6102 AHCL APP 2.5 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000910150 ()


  • Self-care monitoring/reporting software

MiniMed ™ Mobile - 00763000910143

SFTWR MMT-6101 AHCL APP 2.5 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000910143 ()


  • Self-care monitoring/reporting software

N/A - 00763000975029

SOFTWARE APP A610 DBS CLINICIAN V5.0
MEDTRONIC, INC.
A610
In Commercial Distribution

  • 00763000975029 ()


  • Multiple active implantable device programmer

N/A - 00763000612832

SW APP A90300 RECHAGER APPLICATION V2.0
MEDTRONIC, INC.
A90300
In Commercial Distribution

  • 00763000612832 ()


  • Multiple active implantable device programmer

DIRECTVIEW CR Cassette with HR Screen - 40889971044613

18X24CM DRCTVIEW HR SP APP SCRN
CARESTREAM HEALTH, INC.
DIRECTVIEW CR Cassette with HR Screen
In Commercial Distribution

  • 60889971044617 ()
  • 40889971044613 ()
1044619

  • Digital imaging cassette/phosphor plate

LUX-Dx™ Clinic Assistant app - 00802526607615

LUX-Dx Clinic Assistant app (Mobile application)
BOSTON SCIENTIFIC CORPORATION
622935-100
In Commercial Distribution

  • 00802526607615 ()
622935-100

  • Implantable cardiac device management application software

StealthStation Cranial Software - 00763000125295

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000125295 ()


  • Multi-purpose stereotactic surgery system

StealthStation - 00763000063177

SFW 9735762 APP STEALTH S8 APPLICATION
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000063177 ()


  • Multi-purpose stereotactic surgery system

9340 2WAY BALOON VALVE - 00817136024448

9340 2W INFBAL VLV MRI APP
HANS RUDOLPH, INC.
9340
Not in Commercial Distribution

  • 00817136024448 ()
CR1819

  • Pulmonary function valve

FreeStyle Libre 3 App - 00357599817008

FreeStyle Libre 3 iOS App US
ABBOTT DIABETES CARE INC
72077-01
In Commercial Distribution

  • 00357599817008 ()
72077-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

FreeStyle Libre 3 App - 00357599816001

FreeStyle Libre 3 Android App US
ABBOTT DIABETES CARE INC
72075-01
In Commercial Distribution

  • 00357599816001 ()
72075-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

FreeStyle Libre 2 App - 00357599810009

FreeStyle Libre 2 App iOS US
ABBOTT DIABETES CARE INC
71926-01
In Commercial Distribution

  • 00357599810009 ()
71926-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

FreeStyle Libre 2 App - 00357599809003

FreeStyle Libre 2 App Android US
ABBOTT DIABETES CARE INC
71857-01
In Commercial Distribution

  • 00357599809003 ()
71857-01

  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

PERLA ® - 07640151095420

CC Sleeve
SpineArt SA
CPF-IN 36 00-N
Not in Commercial Distribution

  • 07640151095420 ()
CPF-IN 36 00-N

  • Orthopaedic counter-torque/rod-pushing instrument

PERLA ® - 07640151095338

CC Caliper
SpineArt SA
CPF-IN 27 00-N
Not in Commercial Distribution

  • 07640151095338 ()
CPF-IN 27 00-N

  • Orthopaedic bone calliper

PERLA ® - 07640178975330

CC Caliper
SpineArt SA
CPF-IN 27 00-N
In Commercial Distribution

  • 07640178975330 ()
CPF-IN 27 00-N

  • Orthopaedic bone calliper

Optetrak Logic - 10885862627704

CC Reamer
Exactech, Inc.
SPI-001106
In Commercial Distribution

  • 10885862627704 ()
SPI-001106

  • Bone-resection orthopaedic reamer, reusable

Optetrak Logic - 10885862623836

CC Reamer
Exactech, Inc.
SPI-001109
In Commercial Distribution

  • 10885862623836 ()
SPI-001109

  • Bone-resection orthopaedic reamer, reusable

Optetrak Logic - 10885862623812

CC Reamer
Exactech, Inc.
SPI-001086
In Commercial Distribution

  • 10885862623812 ()
SPI-001086

  • Bone-resection orthopaedic reamer, reusable

NA - 10885862295521

VERIFICATOR CC
Exactech, Inc.
521-50-05
In Commercial Distribution

  • 10885862295521 ()
521-50-05

  • Orthopaedic stereotactic surgery system

CEKA & PRECI-LINE ATTACHMENTS - 04260576942845

PRECI-CLIX CC
Alphadent NV
1256
In Commercial Distribution

  • 04260576942845 ()

  • ball with female and housing
  • Height: 4.1 Millimeter
1256

  • Bar dental precision attachment

AoN Implants - 00840192701503

Analog - CC
FAICO MEDICAL LLC
AAN000000000C
Not in Commercial Distribution

  • 00840192701503 ()


  • Dental implant system

STRIPPER - 00888937907919

STRIPPER CC
ORIGIO INC.
MXL3-STR-CC
In Commercial Distribution

  • 00888937907919 ()


  • Assisted reproduction microtool

SoNoNav® Calibration App - 00643169183407

SOFTWARE 9734472 SONONAV CAL APP FOR SC
MEDTRONIC NAVIGATION, INC.
9734472
In Commercial Distribution

  • 00643169183407 ()


  • Multi-purpose stereotactic surgery system

DreamMapper - 00606959054288

DreamMapper App iOS, Asia-Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054288 ()
1127959

  • Self-care monitoring/reporting software
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