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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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Dexcom Stelo Android Mobile App - 00386270004642

No Description
Dexcom, Inc.
SW14117
In Commercial Distribution

  • 00386270004642 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

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

reSET-O® Mobile App, Android - 10851580008125

reSET-O® Mobile Application running on Android. reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008125 ()


  • Mental health/function therapeutic software, screen-viewed

reSET® Mobile App, Android - 10851580008095

reSET® Mobile Application running on Android. reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse. It is intended to: - increase abstinence from a patient’s substances of abuse during treatment, and - increase retention in the outpatient treatment program.
PEAR THERAPEUTICS, INC.
1
In Commercial Distribution

  • 10851580008095 ()


  • Mental health/function therapeutic software, screen-viewed

Eversense® Mobile App Android - 00817491023612

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

  • 00817491023612 ()
FG-5502-01-300

  • Implantable glucose monitoring system

Eversense NOW Mobile App Android - 00817491023490

The Eversense NOW Remote Monitoring App is intended for home use. The mobile app is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information. The secondary display is not a replacement for either real time continuous glucose monitoring using the Eversense CGM System’s primary display, or for home blood glucose monitoring. The Eversense NOW Remote Monitoring App is not intended to be used to make treatment decisions or therapy adjustments.
SENSEONICS, INCORPORATED
FG-5902-01-300
In Commercial Distribution

  • 00817491023490 ()
FG-5902-01-300

  • Implantable glucose monitoring system

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

Medela Family Pump Control - 07612367088527

Smartphone app that enables the user to connect to Medela breast pump. Once connected the app allows the user to control the pump remotely
Medela AG
101046623
In Commercial Distribution

  • 07612367088527 ()


  • Breast pump, electric

EXACT CYLINDRICAL REAMER - 00880304396784

No Description
Biomet Orthopedics, LLC
595099
In Commercial Distribution

  • 00880304396784 ()

  • 8MM TO 20MM
595099

  • Instrument tray, reusable

VERTEX® Reconstruction System - 00613994514493

ROD 7755123 3.2MM/3.5MM X 220 OCCIP ADJ
MEDTRONIC SOFAMOR DANEK, INC.
7755123
In Commercial Distribution

  • 00613994514493 ()

  • Length: 220.0 Millimeter
  • 3.2 to 3.5MM


  • Bone-screw internal spinal fixation system rod

Atoll - 10889981033767

Wedding Band 5.5mm to 3.5mm Connector Asm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-23-5550
In Commercial Distribution

  • 10889981033767 ()

  • 5.5mm to 3.5mm
16-23-5550

  • Bone-screw internal spinal fixation system connector

Atoll - 10889981033750

Slimline 3.5mm to 5.5mm Connector Asm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-23-5540
In Commercial Distribution

  • 10889981033750 ()

  • 3.5mm to 5.5mm
16-23-5540

  • Bone-screw internal spinal fixation system connector

Atoll - 10889981033743

Clamshell 3.5mm to 5.5mm Connector Asm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-23-5530
In Commercial Distribution

  • 10889981033743 ()

  • 3.5mm to 5.5mm
16-23-5530

  • Bone-screw internal spinal fixation system connector

Atoll - 10889981033736

Inline 3.5mm to 5.5mm Connector Asm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-23-5520
In Commercial Distribution

  • 10889981033736 ()

  • 3.5mm to 5.5mm
16-23-5520

  • Bone-screw internal spinal fixation system, non-sterile

Atoll - 10889981033729

Offset 5.5mm to 3.5mm Connector Asm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-23-5510
In Commercial Distribution

  • 10889981033729 ()

  • 5.5mm to 3.5mm
16-23-5510

  • Bone-screw internal spinal fixation system connector

Atoll - 10889981033712

Clamshell 3.5mm to 3.5mm Connector Asm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-23-3530
Not in Commercial Distribution

  • 10889981033712 ()

  • 3.5mm to 3.5mm
16-23-3530

  • Bone-screw internal spinal fixation system connector

Atoll - 10889981033705

Wedding Band 3.5mm to 3.5mm Connector Asm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-23-3520
In Commercial Distribution

  • 10889981033705 ()

  • 3.5mm to 3.5mm
16-23-3520

  • Bone-screw internal spinal fixation system connector

Atoll - 10889981033699

Offset 3.5mm to 3.5mm Connector Asm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
Seaspine Orthopedics Corporation
16-23-3510
In Commercial Distribution

  • 10889981033699 ()

  • 3.5mm to 3.5mm
16-23-3510

  • Bone-screw internal spinal fixation system connector

Coral - 10889981030209

Inline Connector, 5.5mm to 5.5mm
Seaspine Orthopedics Corporation
10-23-0130
In Commercial Distribution

  • 10889981030209 ()

  • 5.5mm to 5.5mm
10-23-0130

  • Bone-screw internal spinal fixation system, non-sterile

Coral - 10889981030193

Clamshell Connector, 5.5mm to 5.5mm
Seaspine Orthopedics Corporation
10-23-0120
In Commercial Distribution

  • 10889981030193 ()

  • 5.5mm to 5.5mm
10-23-0120

  • Bone-screw internal spinal fixation system connector

Coral - 10889981030186

Wedding Band Connector, 5.5mm to 5.5mm
Seaspine Orthopedics Corporation
10-23-0110
In Commercial Distribution

  • 10889981030186 ()

  • 5.5mm to 5.5mm
10-23-0110

  • Bone-screw internal spinal fixation system connector

Coral - 10889981030179

Domino Connector, 5.5mm to 5.5mm
Seaspine Orthopedics Corporation
10-23-0100
In Commercial Distribution

  • 10889981030179 ()

  • 5.5mm to 5.5mm
10-23-0100

  • Bone-screw internal spinal fixation system connector

ROMEO Posterior Osteosynthesis system - 07640151084561

Cross Connector / Multiaxial Prebent
SpineArt SA
ELL-CC MP 55-S
In Commercial Distribution

  • 07640151084561 ()

  • L55 to 80


  • Bone-screw internal spinal fixation system, sterile

ROMEO Posterior Osteosynthesis system - 07640151084547

Cross Connector / Multiaxial Prebent
SpineArt SA
ELL-CC MP 43-S
In Commercial Distribution

  • 07640151084547 ()

  • L43 to 55


  • Bone-screw internal spinal fixation system, sterile

ROMEO Posterior Osteosynthesis system - 07640151084523

Cross Connector / Multiaxial Prebent
SpineArt SA
ELL-CC MP 36-S
In Commercial Distribution

  • 07640151084523 ()

  • L36 to 43


  • Bone-screw internal spinal fixation system, sterile

ROMEO Posterior Osteosynthesis system - 07640151084509

Cross Connector / Multiaxial Prebent
SpineArt SA
ELL-CC MP 33-S
In Commercial Distribution

  • 07640151084509 ()

  • L33 to L36


  • Bone-screw internal spinal fixation system, sterile

ROMEO Posterior Osteosynthesis system - 07640151084073

Cross Connector / Multiaxial
SpineArt SA
ELL-CC MU 43-S
In Commercial Distribution

  • 07640151084073 ()

  • L43 to 55


  • Bone-screw internal spinal fixation system, sterile

ROMEO Posterior Osteosynthesis system - 07640151084066

Cross Connector / Multiaxial
SpineArt SA
ELL-CC MU 36-S
In Commercial Distribution

  • 07640151084066 ()

  • L36 to 43


  • Bone-screw internal spinal fixation system, sterile

ROMEO Posterior Osteosynthesis system - 07640151084059

Cross Connector / Multiaxial
SpineArt SA
ELL-CC MU 33-S
In Commercial Distribution

  • 07640151084059 ()

  • L33 to 36


  • Bone-screw internal spinal fixation system, sterile

ROMEO Posterior Osteosynthesis system - 07640151084042

Cross Connector / Multiaxial
SpineArt SA
ELL-CC MU 31-S
In Commercial Distribution

  • 07640151084042 ()

  • L31 to 33


  • Bone-screw internal spinal fixation system, sterile

ROMEO Posterior Osteosynthesis system - 07640151084035

Cross Connector / Multiaxial
SpineArt SA
ELL-CC MU 30-S
In Commercial Distribution

  • 07640151084035 ()

  • L30 to 31


  • Bone-screw internal spinal fixation system, sterile

ROMEO Posterior Osteosynthesis system - 07640151082512

Cross Connector / Multiaxial
SpineArt SA
ELL-CC MU 55-S
In Commercial Distribution

  • 07640151082512 ()

  • L55 to 80


  • Bone-screw internal spinal fixation system, sterile

MEDENTiKA - EMKA8515309

Multi-unit Laboratory implant
MEDENTiKA GmbH
8515-30
In Commercial Distribution

  • 04251574835093 ()
  • EMKA8515309 ()

  • compatible to Multi-unit
8515-30

  • Dental implant analog

MEDENTiKA - EMKA8515179

Multi-unit Laboratory implant
MEDENTiKA GmbH
8515-17
In Commercial Distribution

  • 04251574835086 ()
  • EMKA8515179 ()

  • compatible to Multi-unit
8515-17

  • Dental implant analog

MEDENTiKA - EMKA8514309

Multi-unit Laboratory implant
MEDENTiKA GmbH
8514-30
In Commercial Distribution

  • 04251574805881 ()
  • EMKA8514309 ()

  • compatible to Multi-unit
8514-30

  • Dental implant analog

MEDENTiKA - EMKA8514179

Multi-unit Laboratory implant
MEDENTiKA GmbH
8514-17
In Commercial Distribution

  • 04251574805874 ()
  • EMKA8514179 ()

  • compatible to Multi-unit
8514-17

  • Dental implant analog

MEDENTiKA - EMKA85109

Multi-unit Laboratory implant
MEDENTiKA GmbH
8510
In Commercial Distribution

  • 04251574805867 ()
  • EMKA85109 ()

  • compatible to Multi-unit
8510

  • Dental implant analog

MEDENTiKA - EMKA85099

Multi-unit Laboratory implant
MEDENTiKA GmbH
8509
In Commercial Distribution

  • 04251574835079 ()
  • EMKA85099 ()

  • compatible to Multi-unit
8509

  • Dental implant analog

MEDENTiKA - EMKA85049

Multi-unit Laboratory implant
MEDENTiKA GmbH
8504
In Commercial Distribution

  • 04251574805850 ()
  • EMKA85049 ()

  • compatible to Multi-unit
8504

  • Dental implant analog
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