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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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L4R DAMON Q WELDABLE 22 -5/4/0 SUPER TQ
ORMCO CORPORATION
161-8442
In Commercial Distribution

  • 10889989020226 ()
  • 00889989020229 ()

  • Slot size 022, Torque -5, Angulation 4


  • Orthodontic bracket, metal
L4L DAMON Q WELDABLE 22 -12/4/0 STD TQ
ORMCO CORPORATION
161-8441
In Commercial Distribution

  • 10889989020219 ()
  • 00889989020212 ()

  • Slot size 022, Torque -12, Angulation 4


  • Orthodontic bracket, metal
L4R DAMON Q WELDABLE 22 -12/4/0 STD TQ
ORMCO CORPORATION
161-8440
In Commercial Distribution

  • 10889989020202 ()
  • 00889989020205 ()

  • Slot size 022, Torque -12, Angulation 4


  • Orthodontic bracket, metal
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-040
In Commercial Distribution

  • 09348215061746 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-050
In Commercial Distribution

  • 09348215058289 ()


  • Fluted surgical drill bit, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
192-072-020
In Commercial Distribution

  • 09348215058258 ()


  • Fluted surgical drill bit, reusable
The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). The Q Patch ECG recorder snaps onto the two off-the-shelf electrodes (Solid gel, Ag/AgCl) and records patient’s ECG for up to 15 days powered from single disposable, non-rechargeable battery. The Q Patch Mobile Application is used to initiate recording session, for checking Q Patch status and to finish/stop the session if needed. When the recording is finished, the ECG data stored in Q Patch’s memory can be downloaded through a USB port using the Q Patch Downloader (PC application).
MEDICALGORITHMICS S A
P5HP-AA-ADS
In Commercial Distribution

  • 05903021560124 ()


  • Electrocardiographic ambulatory recorder
No Description
SOMATEX Medical Technologies GmbH
271500
Not in Commercial Distribution

  • 04250195604613 ()
  • 04250195603081 ()

  • Needle Length, 12 cm
  • Needle Gauge: 18 Gauge
271500

  • Radiological image marker, implantable
No Description
Zimmer MedizinSysteme GmbH
5552
In Commercial Distribution

  • 04053815074410 ()
5552

  • Electromechanical orthopaedic extracorporeal shock wave therapy system
SUTURE
RIVERPOINT MEDICAL, LLC
Q493C
In Commercial Distribution

  • 10812444024705 ()
  • 00812444024708 ()


  • Poliglecaprone suture
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