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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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Meridian Medical - 00081506704258

APP PAD W/HEAD & FOOT FLAPS
COMPASS HEALTH BRANDS CORP.
1002F
In Commercial Distribution

  • 30815067042556 ()
  • 00081506704258 ()


  • Alternating-pressure bed mattress overlay, reusable

9340 2WAY BALOON VALVE - 00817136024448

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

  • 00817136024448 ()
CR1819

  • Pulmonary function valve

CARDINAL HEALTH - 10885425518302

STRL ALLENTWN LAP CHOLE APP PK
Cardinal Health 200, LLC
SLC11LLSLG
In Commercial Distribution

  • 50885425518300 ()
  • 10885425518302 ()
SLC11LLSLG

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

Nalu Medical, Inc. - 00812537033013

SCS Remote App (compatible with iOS)
NALU MEDICAL, INC.
53002-002
In Commercial Distribution

  • 00812537033013 ()
53002-002

  • Implantable electrical stimulation device management software

Nalu Medical, Inc. - 00812537030470

SCS Remote App (compatible with Android)
NALU MEDICAL, INC.
53002-001
In Commercial Distribution

  • 00812537030470 ()
53002-001

  • Implantable electrical stimulation device management software

PRC - 00816486021084

LAMP Words For Life (US) App
PRENTKE ROMICH COMPANY
LAMP WFL App
In Commercial Distribution

  • 00816486021084 ()
16659

  • Voice synthesizer/digitizer

PRC - 00816486021077

LAMP Words For Life (UK) App
PRENTKE ROMICH COMPANY
LAMP WFL (UK) App
In Commercial Distribution

  • 00816486021077 ()
16659-2

  • Voice synthesizer/digitizer

N/A - 00763000273668

SW APP A71100 SCS RESTORE CLINICIAN
MEDTRONIC, INC.
A71100
In Commercial Distribution

  • 00763000273668 ()


  • Multiple active implantable device programmer

StealthStation Cranial Software - 00763000234867

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

  • 00763000234867 ()


  • Multi-purpose stereotactic surgery system

N/A - 00763000159092

SW APP A52200 GU PATIENT PERFICIO
MEDTRONIC, INC.
A52200
In Commercial Distribution

  • 00763000159092 ()


  • Multiple active implantable device programmer

N/A - 00763000159085

SW APP A51200 GU CLINICIAN PERFICIO
MEDTRONIC, INC.
A51200
In Commercial Distribution

  • 00763000159085 ()


  • Multiple active implantable device programmer

Guardian™ Connect App - 00763000158392

SFTWR CSS7200 GRDN IOS APP V3.2.1
MEDTRONIC MINIMED, INC.
CSS7200
In Commercial Distribution

  • 00763000158392 ()


  • Patient health record information system application software

StealthStation Cranial Software - 00763000368494

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

  • 00763000368494 ()


  • Multi-purpose stereotactic surgery system

N/A - 00763000287306

SW APP A72300 SCS PATIENT TRIALING
MEDTRONIC, INC.
A72300
In Commercial Distribution

  • 00763000287306 ()


  • Multiple active implantable device programmer

N/A - 00763000287276

SW APP A71300 SCS CLINICIAN TRIALING
MEDTRONIC, INC.
A71300
In Commercial Distribution

  • 00763000287276 ()


  • Multiple active implantable device programmer

StealthStation Cranial Software - 00763000125295

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

  • 00763000125295 ()


  • Multi-purpose stereotactic surgery system

N/A - 00763000024024

SW APP A520 GU PATIENT CHRONIC
MEDTRONIC, INC.
A520
In Commercial Distribution

  • 00763000024024 ()


  • Multiple active implantable device programmer

N/A - 00763000024017

SW APP A510 GU CLINICIAN CHRONIC
MEDTRONIC, INC.
A510
In Commercial Distribution

  • 00763000024017 ()


  • Multiple active implantable device programmer

StealthStation - 00763000063177

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

  • 00763000063177 ()


  • Multi-purpose stereotactic surgery system

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

PILLING - 24026704507102

LARGE VESS APP 15MM TAPERED BLADES
TELEFLEX INCORPORATED
IPN002336
In Commercial Distribution

  • 04026704507108 ()
  • 24026704507102 ()

  • Length: 1.625 Inch
  • Width: 1 Inch
065196

  • Surgical bulldog clamp, reusable

N/A - 00763000975029

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

  • 00763000975029 ()


  • Multiple active implantable device programmer

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 - 00763000416676

SFTWR MMT-6102 AHCL APP 1.3.3 IOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000416676 ()


  • Self-care monitoring/reporting software

MiniMed ™ Mobile - 00763000416669

SFTWR MMT-6101 AHCL APP 1.3.2 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000416669 ()


  • Self-care monitoring/reporting software

MiniMed™ Mobile - 00763000827793

Sftwr MMT-6102 AHCL 2.1.1 App iOS
MEDTRONIC MINIMED, INC.
MMT-6102
In Commercial Distribution

  • 00763000827793 ()


  • Self-care monitoring/reporting software

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 - 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
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