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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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Eversense® Mobile App Android - 00817491022387

Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5502-01-300
Not in Commercial Distribution

  • 00817491022387 ()
FG-5502-01-300

  • Implantable glucose monitoring system

Eversense® Mobile App Android - 00817491020826

Eversense CGM Mobile Application (Android) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5600-01-300
Not in Commercial Distribution

  • 00817491020826 ()
FG-5600-01-300

  • Implantable glucose monitoring system

Biomeme GoDx App for US - 00810096640130

App for controlling Biomeme Frankin three9 thermocycler when used with the Biomeme Real-Time RT-PCR SARS-CoV-2 Test
Biomeme, Inc.
2.3.5
In Commercial Distribution

  • 00810096640130 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)

Medtronic Diabetes Updater app Android - 00763000532161

SFTWR MMT-6121 FOTA ANDROID V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6121
In Commercial Distribution

  • 00763000532161 ()


  • Patient health record information system application software

Lumify Diagnostic Ultrasound System iOS Subscription - 00884838103399

No Description
Philips Ultrasound LLC
795160
In Commercial Distribution

  • 00884838103399 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

NobelPearl™ IOS Implant Replica Placer - 07640161395015

Accessories
CeramTec Schweiz GmbH
301291
In Commercial Distribution

  • 07640161395015 ()
301291

  • Dental implant suprastructure, temporary, preformed, single-use

Disposable Electrode Serie - 06924274950608

No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
VIX-A015腔镜电极
In Commercial Distribution

  • 06924274950608 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use

MIR - 08052990321759

Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
MIR SPIROBANK SMART
In Commercial Distribution

  • 08052990321759 ()


  • Expiratory peak flow meter, digital

COHERO - 08052990321636

Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
mSpirometer
In Commercial Distribution

  • 08052990321636 ()


  • Expiratory peak flow meter, digital

MIR - 08052990321124

Smart Spirometer connected to an app available on a smart phone
MIR MEDICAL INTERNATIONAL RESEARCH SPA
MIR SPIROBANK SMART
In Commercial Distribution

  • 08052990321124 ()
911105

  • Expiratory peak flow meter, digital

Vertex-Dental BV - 08719425505121

HD Rapid Simplified / 07 150grhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Vertex-Dental B.V.
HDARSP0700150
Not in Commercial Distribution

  • 08719425505121 ()


  • Dental appliance fabrication material, resin

Nerve Hook - 10840199507525

Hoen Nerve Hook Straight 22cmhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
KOROS U.S.A., INC.
7225-05
In Commercial Distribution

  • 00840199507528 ()
  • 10840199507525 ()

  • 9x12mm
7225-05

  • Soft-tissue surgical hook, reusable

AIR INNOVATIONS - 00180104000813

Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Black
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000813 ()


  • Room humidifier

AIR INNOVATIONS - 00180104000806

Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - White
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000806 ()


  • Room humidifier

AIR INNOVATIONS - 00180104000790

Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Navy
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000790 ()


  • Room humidifier

AIR INNOVATIONS - 00180104000783

Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Red
GREAT INNOVATIONS, LLC
MH-906
In Commercial Distribution

  • 00180104000783 ()


  • Room humidifier

Pisces-SA - B06217607070

6mm Kerrison Rongeur, 350mm https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Osseus Fusion Systems, LLC
1760-7070
In Commercial Distribution

  • B06217607070 ()
1760-7070

  • Spinal rongeur

DRSHD 1080p - 00817613020000

DRSHD 1080p System, Rev 7https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
Nds Surgical Imaging LLC
DRSHD.7
Not in Commercial Distribution

  • 00817613020000 ()


  • Endoscopic video image processing unit

FIBRIJET - 00815634020078

GAS-ASSISTED SPRAY SET ENDOSCOPIC APP. 5MM 30 CM, 1:1 RATIO
Micromedics, Inc.
SA-3654
In Commercial Distribution

  • 10815634020075 ()
  • 00815634020078 ()
  • 20815634020072 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

Invenio - 16931918174532

Gastric Bypass Pack _Sterile_3EA/CShttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
GRI Medical & Electronic Technology Co., Ltd.
LGH011
In Commercial Distribution

  • 26931918174539 ()
  • 16931918174532 ()


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