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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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PROFIX MIS 5-IN-1 STANDARD EXTERNAL ROT GDE LEFT
Smith & Nephew, Inc.
71513368
Not in Commercial Distribution

  • 03596010534026 ()
71513368

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Secondary Dose Check for external beam radiation therapy.
DOSISOFT
2.0.2
In Commercial Distribution

  • B501THINKQA0200020 ()


  • Radiation therapy software
Secondary Dose Check for external beam radiation therapy.
DOSISOFT
2.0.1
In Commercial Distribution

  • B501THINKQA0200010 ()
TK2010, TK2020

  • Radiation therapy software
Secondary Dose Check for external beam radiation therapy.
DOSISOFT
2.0.0
In Commercial Distribution

  • B501THINKQA0200000 ()
TK2010, TK2020

  • Radiation therapy software
Max-550 MaxBlend External Medical Oxygen Sensor Taiwan Labeled
MAXTEC, LLC
Max-550
In Commercial Distribution

  • 00817770025641 ()
R140P02-101

  • Respiratory oxygen sensor
Koala® Intrauterine Pressure Catheter with external balloon
CLINICAL INNOVATIONS, LLC
IPC-5000E
In Commercial Distribution

  • 20814247020172 ()
  • 10814247020175 ()
  • 00814247020178 ()


  • Intrapartum pressure monitoring catheter
Clinical Screw for Ti Biomet 3i External Hex
Nobel Biocare AB
36022
Not in Commercial Distribution

  • 07332747013825 ()
36022

  • Dental prosthesis/implant abutment screw
Wide esthetic 15 angulated abutment external hex. 1mm
MIS Implants Technologies Ltd.
EW-P1510
Not in Commercial Distribution

  • 07290108998733 ()


  • Dental implant suprastructure, permanent, preformed
Wide gold plastic cylinder with hex. external hex.
MIS Implants Technologies Ltd.
EW-GPC10
In Commercial Distribution

  • 07290108998672 ()


  • Dental implant suprastructure, permanent, preformed
Wide cementing post for standard external hex. implants
MIS Implants Technologies Ltd.
ED-WMAC1
Not in Commercial Distribution

  • 07290108997934 ()


  • Dental implant suprastructure, permanent, preformed
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