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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 - 00763000867621

SFTWR MMT-6101 AHCL APP 2.2.1 ANDROID
MEDTRONIC MINIMED, INC.
MMT-6101
In Commercial Distribution

  • 00763000867621 ()


  • Self-care monitoring/reporting software

StealthStation S8 - 00763000852818

SFW 9735762 APP STEALTH S8 V2.1
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000852818 ()


  • Multi-purpose stereotactic surgery system

SteathStation - 00763000532123

SW 9735762 APP STLTH S8 v2.0.1
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00763000532123 ()


  • Multi-purpose stereotactic surgery system

NA - 00763000517199

SW APP A52300 OASIS PATIENT GU
MEDTRONIC, INC.
A52300
In Commercial Distribution

  • 00763000517199 ()


  • Multiple active implantable device programmer

NA - 00763000517182

SW APP A51300 OASIS CLINICIAN GU
MEDTRONIC, INC.
A51300
In Commercial Distribution

  • 00763000517182 ()


  • Multiple active implantable device programmer

InPen Smart Insulin Delivery System - 00763000489960

SOFTWARE MMT-8061 INS PEN ANDROID APP
MEDTRONIC MINIMED, INC.
MMT-8061
In Commercial Distribution

  • 00763000489960 ()


  • Empty self-injector, mechanical

InPen Smart Insulin Delivery System - 00763000489953

SOFTWARE MMT-8060 INSULIN PEN IOS APP
MEDTRONIC MINIMED, INC.
MMT-8060
In Commercial Distribution

  • 00763000489953 ()


  • Empty self-injector, mechanical

Medtronic Navigation - 00763000456986

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

  • 00763000456986 ()


  • Multi-purpose stereotactic surgery system

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 - 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

N/A - 00763000273668

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

  • 00763000273668 ()


  • Multiple active implantable device programmer

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

StealthStation Cranial Software - 00763000368494

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

  • 00763000368494 ()


  • Multi-purpose stereotactic surgery system

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

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

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 - 00763000612832

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

  • 00763000612832 ()


  • Multiple active implantable device programmer

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

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 - 00763000234867

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

  • 00763000234867 ()


  • Multi-purpose stereotactic surgery system

N/A - 00763000024017

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

  • 00763000024017 ()


  • Multiple active implantable device programmer

N/A - 00763000024024

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

  • 00763000024024 ()


  • 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

StealthStation Cranial Software - 00763000125295

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

  • 00763000125295 ()


  • Multi-purpose stereotactic surgery system

IVA Cage - 08800039829861

IVA ACIF CAGE (Flat) L12 x W14 x A10 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039829861 ()
ACF.12141005

  • Spinal fixation plate, non-bioabsorbable

IVA Cage - 08800039829557

IVA ACIF CAGE (Flat) L15 x W17 x A10 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039829557 ()
ACF.15171005

  • Spinal fixation plate, non-bioabsorbable

IVA Cage - 08800039829441

IVA ACIF CAGE (Flat) L14 x W16 x A10 x H5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08800039829441 ()
ACF.14161005

  • Spinal fixation plate, non-bioabsorbable

NORDENT MANUFACTURING INC - 00840018623170

SCALER, SINGLE END, TRADE IN, SICKLE N5 (H5), #6 RELYANT HANDLE
NORDENT MANUFACTURING INC
TSCN5
In Commercial Distribution

  • 00840018623170 ()


  • Manual dental scaler, reusable

30GR ANGLED PAD ABUT., H5 MM - D7701254113

30GR ANGLED PAD ABUT., H5 MM D.5.00 MM EX.2.30
SWEDEN & MARTINA SPA
AS-PAD-AA500-305
In Commercial Distribution

  • D7701254113 ()
AS-PAD-AA500-305

  • Dental implant suprastructure, permanent, preformed

17GR ANGLED PAD ABUT., H5 MM - D7701254093

17GR ANGLED PAD ABUT., H5 MM D.5.00 MM EX.2.30
SWEDEN & MARTINA SPA
AS-PAD-AA500-175
In Commercial Distribution

  • D7701254093 ()
AS-PAD-AA500-175

  • Dental implant suprastructure, permanent, preformed

30GR ANGLED PAD ABUT., H5 MM - D7701245913

30GR ANGLED PAD ABUT., H5 MM D.4.25 MM EX.2.30
SWEDEN & MARTINA SPA
AS-PAD-AA425-305
In Commercial Distribution

  • D7701245913 ()
AS-PAD-AA425-305

  • Dental implant suprastructure, permanent, preformed

17GR ANGLED PAD ABUT., H5 MM - D7701245893

17GR ANGLED PAD ABUT., H5 MM D.4.25 MM EX.2.30
SWEDEN & MARTINA SPA
AS-PAD-AA425-175
In Commercial Distribution

  • D7701245893 ()
AS-PAD-AA425-175

  • Dental implant suprastructure, permanent, preformed

Laryseal Blue Laryngeal Mask Airway Slimline Pack Size 2 - 05055788777694

https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
FLEXICARE MEDICAL LIMITED
038-94-620U
In Commercial Distribution

  • 05055788777694 ()


  • Laryngeal mask airway, single-use

SoNoNav® Calibration App - 00643169183407

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

  • 00643169183407 ()


  • Multi-purpose stereotactic surgery system

Halo Systems - 05690977308695

OB V2 RING KIT TI LG-No App
OSSUR AMERICAS, INC.
515500V2
Not in Commercial Distribution

  • 05690977308695 ()
515500V2

  • Cervical spine immobilization head ring

Halo Systems - 05690977308688

OB V2 RING KIT TI STD-No App
OSSUR AMERICAS, INC.
515400V2
Not in Commercial Distribution

  • 05690977308688 ()
515400V2

  • Cervical spine immobilization head ring

Halo Systems - 05690977308671

OB V2 RING KIT TI SM-No App
OSSUR AMERICAS, INC.
515300V2
Not in Commercial Distribution

  • 05690977308671 ()
515300V2

  • Cervical spine immobilization head ring

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

DreamMapper - 00606959054271

DreamMapper App iOS, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054271 ()
1128264

  • Self-care monitoring/reporting software

Dexcom G5 Mobile IOS App - 00386270000002

G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Dexcom G5 Mobile Android App - 00386270000293

G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution

  • 00386270000293 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Thermo Scientific - 00673693398572

Rabbit Polyclonal Anti-Human Amyloid Precursor Protein (APP)
RICHARD-ALLAN SCIENTIFIC COMPANY
RB-9023-P1
In Commercial Distribution

  • 00673693398572 ()

  • Total Volume: 0.5 Milliliter


  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
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