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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 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 CGM Mobile Application (iOS) 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-5501-01-300
Not in Commercial Distribution

  • 00817491022370 ()
FG-5501-01-300

  • Implantable glucose monitoring system
For the wireless mode version of the subject device, combined with an application installed on a tablet that can be used in a home environment, the content of the SPM01K4 convenience kit is: 1 electrostimulator SPM01M1 configuration; electrodes; protective skin, and 1 tablet with the MySPM@Home mobile application (SPM01A2).
NCS LAB SRL
SPM01K4
In Commercial Distribution

  • 08051122040971 ()
SPM01K4

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
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)
SFTWR MMT-6122 FOTA IOS V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6122
In Commercial Distribution

  • 00763000532178 ()


  • Patient health record information system application software
SFTWR MMT-6121 FOTA ANDROID V1.3.4
MEDTRONIC MINIMED, INC.
MMT-6121
In Commercial Distribution

  • 00763000532161 ()


  • Patient health record information system application software
Esthet-X®flow Liquid Micro Hybrid, U, 20 Compula® Tips Refill Package
DENTSPLY INTERNATIONAL INC.
648115
In Commercial Distribution

  • D0026481151 ()
  • D0026481150 ()

  • Esthet-X®flow Liquid Micro Hybrid U, 20 Compula® Tips
  • Weight: 0.25 Gram
648115

  • Dental composite resin
+ DAMON CLR SPK U/L 7-7 STD-TQ W. CLR U/L 3-3
ORMCO CORPORATION
740-1406
In Commercial Distribution

  • 00889989080476 ()

  • Slot size: .022"


  • Orthodontic bracket, ceramic
+ DAMON CLR SPK U/L 5-5 STD-TQ W. CLR U/L 3-3
ORMCO CORPORATION
740-1407
In Commercial Distribution

  • 00889989080483 ()

  • Slot size: .022"


  • Orthodontic bracket, ceramic
D Cap Gravity Feeding Set with ENFit Connector
U DELIVER MEDICAL L.L.C.
BK-2260
In Commercial Distribution

  • 00860136002466 ()
  • 00860136002473 ()


  • Enteral feeding noninvasive-component set
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