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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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The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 6.5mm compression screw head in order to initiate the anchoring of the screw head.
NEWDEAL
119590ND
In Commercial Distribution

  • M248119590ND1 ()
  • 10381780051480 ()

  • 10.5mm inner/11.5mm outer diameter X 80mm length


  • Bone trephine, reusable
The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 4.0mm compression screw head in order to initiate the anchoring of the screw head.
NEWDEAL
119580ND
In Commercial Distribution

  • M248119580ND1 ()
  • 10381780051473 ()

  • 6.5mm inner/7.5mm outer diameter X 70mm length


  • Bone trephine, reusable
The SuperBar is a high quality, commercial grade pivoting and locking horizontal bar that connects to the SuperPole (floor to ceiling safety pole). The horizontal bar can be lifted, pivoted and lowered to the next locking position around the SuperPole. The SuperBar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperBar is installed onto the SuperPole by securing a castellated collar to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the collar in place, and the spring ring is used to prevent the set screws from back-threading. The castellated collar has 8 grooves (every 45 degrees) to provide a mechanism strong enough for the SuperBar to support the user. It is important to set proper height and orientation of the SuperBar to optimize the user’s range of motion. The SuperBar is made from robust materials and is capable of supporting vigorous forces during proper / normal usage. The structural components of the pole are made from metal. The plastic bushings of the SuperBar allow the horizontal bar to be rotated without marking or damaging the pole.
Healthcraft Products Inc.
SPB-AK
In Commercial Distribution

  • 00689281014724 ()
01472

  • Hand rail
DreamMapper Android APAC Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051317 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Android EU Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051300 ()
1128265

  • Self-care monitoring/reporting software
DreamMapper Android NA Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051294 ()
1101479

  • Self-care monitoring/reporting software
DreamMapper Android APAC Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049079 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Android EU Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049062 ()
1128265

  • Self-care monitoring/reporting software
DreamMapper Android APAC Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049918 ()
1127960

  • Self-care monitoring/reporting software
DreamMapper Android EU Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049901 ()
1128265

  • Self-care monitoring/reporting software
DreamMapper Android NA Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049895 ()
1101479

  • Self-care monitoring/reporting software
DreamMapper Android NA Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049055 ()
1101479

  • Self-care monitoring/reporting software
No Description
Dexcom, Inc.
SW14131
In Commercial Distribution

  • 00386270004659 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
No Description
Dexcom, Inc.
SW14117
In Commercial Distribution

  • 00386270004642 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
No Description
Dexcom, Inc.
SW14116
In Commercial Distribution

  • 00386270004635 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical
DreamMapper Mobile Application Android (EMEA)
Respironics, Inc.
2.5
In Commercial Distribution

  • 00606959042025 ()
1128265

  • Self-care monitoring/reporting software
Eko mobile app for android international platforms for use with Eko medical devices.
Eko Devices, Inc.
com.ekodevices.android.intl
In Commercial Distribution

  • 00850010298061 ()


  • Medical equipment clinical data interfacing software
No Description
Infinitus Medical Technologies LLC
FPLS-3000
In Commercial Distribution

  • 00860003986806 ()
FPLS-3000

  • Operating table patient positioning set, single-use
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 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

  • 00817491023605 ()
FG-5501-01-300

  • Implantable glucose monitoring system
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
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
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-5500-01-300
Not in Commercial Distribution

  • 00817491020819 ()
FG-5500-01-300

  • Implantable glucose monitoring system
No Description
BIOTRONIK SE & Co. KG
493241
In Commercial Distribution

  • 04035479188733 ()
493241

  • Implantable electrical stimulation device management software
No Description
BIOTRONIK SE & Co. KG
487878
In Commercial Distribution

  • 04035479185817 ()
487878

  • Implantable electrical stimulation device management software
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
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
267363
In Commercial Distribution

  • 03661489673634 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
NXSTAGE MEDICAL, INC.
NX1379
Not in Commercial Distribution

  • M535NX1225NX1379 ()


  • Medical equipment clinical data interfacing software
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
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