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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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EXTERNAL CHECK ROD
ONKOS SURGICAL, INC.
K0000901E
In Commercial Distribution

  • B278K0000901E0 ()
K0000901E

  • General internal orthopaedic fixation system implantation kit
EXTERNAL CHECK GUIDE
ONKOS SURGICAL, INC.
K0000900E
In Commercial Distribution

  • B278K0000900E0 ()
K0000900E

  • General internal orthopaedic fixation system implantation kit
EXTERNAL TOCODYNAMOMETER TRANSDUCER
PARKER-HANNIFIN CORPORATION
TDP-BH
In Commercial Distribution

  • B249VA003121 ()
  • VA003121 ()
  • VA00312 ()
VA00312

  • Tocodynamometer probe
EXTERNAL TOCODYNAMOMETER TRANSDUCER
PARKER-HANNIFIN CORPORATION
TDP-BH
In Commercial Distribution

  • B249VA003120 ()
  • VA003120 ()
VA00312

  • Tocodynamometer probe
EXTERNAL TOCODYNAMOMETER TRANSDUCER
PARKER-HANNIFIN CORPORATION
TDP-NB
In Commercial Distribution

  • B249VA003101 ()
  • VA003101 ()
  • VA00310 ()
VA00310

  • Tocodynamometer probe
EXTERNAL TOCODYNAMOMETER TRANSDUCER
PARKER-HANNIFIN CORPORATION
TDP-NB
In Commercial Distribution

  • B249VA003100 ()
  • VA003100 ()
VA00310

  • Tocodynamometer probe
EXTERNAL TOCODYNAMOMETER TRANSDUCER
PARKER-HANNIFIN CORPORATION
TD-NB
In Commercial Distribution

  • B249VA001061 ()
  • VA001061 ()
  • VA00106 ()
VA00106

  • Tocodynamometer probe
EXTERNAL TOCODYNAMOMETER TRANSDUCER
PARKER-HANNIFIN CORPORATION
TD-NB
In Commercial Distribution

  • B249VA001060 ()
  • VA001060 ()
VA00106

  • Tocodynamometer probe
EXTERNAL TOCODYNAMOMETER TRANSDUCER
PARKER-HANNIFIN CORPORATION
TD-BH
In Commercial Distribution

  • B249VA000381 ()
  • VA000381 ()
  • VA00038 ()
VA00038

  • Tocodynamometer probe
EXTERNAL TOCODYNAMOMETER TRANSDUCER
PARKER-HANNIFIN CORPORATION
TD-BH
In Commercial Distribution

  • B249VA000380 ()
  • VA000380 ()
VA00038

  • Tocodynamometer probe
EXTERNAL ALIGNMENT HANDLE
Howmedica Osteonics Corp.
3180-1000
In Commercial Distribution

  • 07613327215687 ()
3180-1000

  • Orthopaedic prosthesis implantation positioning instrument, reusable
External Counter Torque
CAMBER SPINE TECHNOLOGIES, LLC
CM-132-03
In Commercial Distribution

  • B030CM132030 ()


  • Orthopaedic counter-torque/rod-pushing instrument
External Counter Torque
CAMBER SPINE TECHNOLOGIES, LLC
CM-132-02
In Commercial Distribution

  • B030CM132020 ()


  • Orthopaedic counter-torque/rod-pushing instrument
Solid External Sheath
ARTHREX, INC.
IN0165
Not in Commercial Distribution

  • 00816988011248 ()
IN0165

  • Surgical drill guide, reusable
ExFeel External M2
Megagen Implant Co. Ltd
RDC100
In Commercial Distribution

  • 08806388231430 ()
RDC100

  • Dental implant suprastructure, permanent, preformed
Rescue Ex External
Megagen Implant Co. Ltd
MOW400
In Commercial Distribution

  • 08806388228133 ()
MOW400

  • Surgical screwdriver, reusable
Rescue External M2.5
Megagen Implant Co. Ltd
LWCS250
In Commercial Distribution

  • 08806388225392 ()
LWCS250

  • Dental implant suprastructure, permanent, preformed
Rescue External Ø5
Megagen Implant Co. Ltd
LWC100
In Commercial Distribution

  • 08806388225217 ()
LWC100

  • Dental implant suprastructure, permanent, preformed
EXTERNAL IRRIGATION DRILL
HI-TEC IMPLANTS LTD.
RTD-XR ø 5.20mm
In Commercial Distribution

  • 07290110722524 ()
RTD-XR

  • Dental implant/prosthesis surgical procedure kit
EXTERNAL IRRIGATION DRILL
HI-TEC IMPLANTS LTD.
WTD-XR ø 4.30mm
In Commercial Distribution

  • 07290110722517 ()
WTD-XR

  • Dental implant/prosthesis surgical procedure kit
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