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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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Two Hole Plate, SS
ARTHREX, INC.
AR-8958-01
In Commercial Distribution

  • 00888867251922 ()
  • M150AR8958010 ()
AR-8958-01

  • Orthopaedic fixation plate, non-bioabsorbable
TL+ TWO HOLE POST
ORTHOFIX SRL
1
In Commercial Distribution

  • 18033509856761 ()
54-11610

  • External orthopaedic fixation system, single-use
Suture Passer & Two Guides
STRYKER SUSTAINABILITY SOLUTIONS, INC.
N/A
In Commercial Distribution

  • 30885825013319 ()
  • 00885825013318 ()
CTI-512N

  • Suturing unit, reprocessed
SUCCESSION TWO CIRCLE DRILL
ORTHO SOLUTIONS HOLDINGS LIMITED
OS353005-S
In Commercial Distribution

  • 05055662970630 ()
OS353005-S

  • Cannulated surgical drill bit, single-use
4mm Hysteroscopy Sheath, with Two Channel, and Two Rotatable Stop Cocks
Surgical Direct, Inc.
SD23009
In Commercial Distribution

  • B382SD230090 ()

  • Outer Diameter: 4 Millimeter
SD23009

  • Endoscope sheath, reusable
ERGO Periotom KIT with 4 exchangeable inserts. (two straight two curved)
A. Schweickhardt GmbH & Co. KG
1706-45
In Commercial Distribution

  • E8961706450 ()
1706-45

  • Periosteal elevator, reusable
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., 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
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