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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tomas® anchorage system: tomas®-wheel, ø 10 mm (Nut)
DENTAURUM GmbH & Co.KG
302-004-30
In Commercial Distribution

  • J011302004300 ()


  • Surgical screwdriver, reusable
tomas® anchorage system: tomas®-applicator (manual screwing aid)
DENTAURUM GmbH & Co.KG
302-004-20
In Commercial Distribution

  • J011302004200 ()


  • Surgical screwdriver, reusable
tomas® anchorage system: tomas®-screwdriver tip
DENTAURUM GmbH & Co.KG
302-004-18
In Commercial Distribution

  • J011302004180 ()


  • Surgical screwdriver, reusable
tomas® anchorage system: tomas®-screw driver allen set screw
DENTAURUM GmbH & Co.KG
302-004-15
Not in Commercial Distribution

  • J011302004150 ()


  • Surgical screwdriver, reusable
tomas® anchorage system: tomas®-screw driver handle
DENTAURUM GmbH & Co.KG
302-004-11
In Commercial Distribution

  • J011302004110 ()


  • Surgical screwdriver, reusable
SET SCREW EX0213010 RETAINING DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX0213010
In Commercial Distribution

  • 00643169322134 ()


  • Orthopaedic implant driver
Distractor Driver
K2M, INC.
7902-90092
In Commercial Distribution

  • 10888857399112 ()
7902-90092

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tapered Driver Size 27, Long
K2M, INC.
7012-90103
In Commercial Distribution

  • 10888857398382 ()
7012-90103

  • Orthopaedic prosthesis implantation positioning instrument, reusable
INST KIT 9735197 FIGHTR INSRT/REMVL TOOL
MEDTRONIC NAVIGATION, INC.
9735197
In Commercial Distribution

  • 00643169310292 ()


  • Surgical screwdriver, reusable
DRIVER X1212033 T27 UNIVERSAL JOINT
MEDTRONIC SOFAMOR DANEK, INC.
X1212033
In Commercial Distribution

  • 00643169310049 ()


  • Orthopaedic implant driver
Pump Driver Module
APMTD, Inc.
SG1000-PDM-004
In Commercial Distribution

  • 00850000067097 ()
SG1000-PDM-004

  • Cardiopulmonary bypass system centrifugal pump drive unit
Pump Driver Module
APMTD, Inc.
SG1000-PDM-003
In Commercial Distribution

  • 00850000067080 ()
SG1000-PDM-003

  • Cardiopulmonary bypass system centrifugal pump drive unit
Pump Driver Module
APMTD, Inc.
SG1000-PDM-002
In Commercial Distribution

  • 00850000067073 ()
SG1000-PDM-002

  • Cardiopulmonary bypass system centrifugal pump drive unit
Pump Driver Module
APMTD, Inc.
SG1000-PDM-001
In Commercial Distribution

  • 00850000067066 ()
SG1000-PDM-001

  • Cardiopulmonary bypass system centrifugal pump drive unit
DRIVER EX0317005 T8
MEDTRONIC SOFAMOR DANEK, INC.
EX0317005
In Commercial Distribution

  • 00643169980662 ()


  • Surgical screwdriver, reusable
DRIVER EX0317004 T10
MEDTRONIC SOFAMOR DANEK, INC.
EX0317004
In Commercial Distribution

  • 00643169980655 ()


  • Surgical screwdriver, reusable
SCREWDRIVER EX0416052 U JOINT T25
MEDTRONIC SOFAMOR DANEK, INC.
EX0416052
In Commercial Distribution

  • 00643169783652 ()


  • Surgical screwdriver, reusable
DRIVER X1215009 TAMPONADE
MEDTRONIC SOFAMOR DANEK, INC.
X1215009
In Commercial Distribution

  • 00643169789326 ()


  • Surgical screwdriver, reusable
REMOVAL BIT X0815014 T27 WITH OBTURATOR
MEDTRONIC SOFAMOR DANEK, INC.
X0815014
In Commercial Distribution

  • 00643169785984 ()


  • Surgical screwdriver, reusable
DRIVER X0714017 6.35MM PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
X0714017
In Commercial Distribution

  • 00643169785960 ()


  • Orthopaedic implant driver
SCREWDRIVER X0714014 FIXED AXIAL
MEDTRONIC SOFAMOR DANEK, INC.
X0714014
In Commercial Distribution

  • 00643169785939 ()


  • Orthopaedic implant driver
SCREWDRIVER X0714013 MULTI AXIAL
MEDTRONIC SOFAMOR DANEK, INC.
X0714013
In Commercial Distribution

  • 00643169785922 ()


  • Orthopaedic implant driver
DRIVER 6550031 5.5/6.0 SV NUT DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6550031
In Commercial Distribution

  • 00643169785687 ()


  • Surgical screwdriver, reusable
ATHERECTOMY H1-14550 CUTTER DRIVER V03
Covidien LP
H1-14550
In Commercial Distribution

  • 00643169777644 ()


  • Mechanical atherectomy system catheter, peripheral
SCREWDRIVER EX0117067 SHORTEN STRGHT HEX
MEDTRONIC SOFAMOR DANEK, INC.
EX0117067
In Commercial Distribution

  • 00643169957329 ()


  • Surgical screwdriver, reusable
DRIVER EX0117005 SET SCRW RETAINING 4.75
MEDTRONIC SOFAMOR DANEK, INC.
EX0117005
In Commercial Distribution

  • 00643169953284 ()


  • Orthopaedic implant driver
DRIVER EX1016091 MAS SHORT 4.75MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1016091
In Commercial Distribution

  • 00643169953086 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER EX1016090 MAS SHORT 5.5/6.0MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1016090
In Commercial Distribution

  • 00643169953079 ()


  • General internal orthopaedic fixation system implantation kit
INSTRUMENT EX1116116 SCREW REMOVAL T8T10
MEDTRONIC SOFAMOR DANEK, INC.
EX1116116
In Commercial Distribution

  • 00643169949997 ()


  • Surgical screwdriver, reusable
DRIVER EX1116062 T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1116062
In Commercial Distribution

  • 00643169937987 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER EX0616012 SHORTEN T8-T10
MEDTRONIC SOFAMOR DANEK, INC.
EX0616012
In Commercial Distribution

  • 00643169800106 ()


  • Surgical screwdriver, reusable
DRIVER X0416007 NUT 4.75 REDUCER
MEDTRONIC SOFAMOR DANEK, INC.
X0416007
In Commercial Distribution

  • 00643169800045 ()


  • Orthopaedic rod reducer
REDUCER X0416006 4.75
MEDTRONIC SOFAMOR DANEK, INC.
X0416006
In Commercial Distribution

  • 00643169800038 ()


  • Surgical screwdriver, reusable
SCREWDRIVER EX0616081 RETNG BONE 5.5/6.0
MEDTRONIC SOFAMOR DANEK, INC.
EX0616081
In Commercial Distribution

  • 00643169799950 ()


  • Surgical screwdriver, reusable
AWL EX0616054 STRGHT FLEXIBLE-TROCAR TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0616054
In Commercial Distribution

  • 00643169799660 ()


  • Surgical screwdriver, reusable
DRIVER EX0516002 SHORT PLATE HOLDING PIN
MEDTRONIC SOFAMOR DANEK, INC.
EX0516002
In Commercial Distribution

  • 00643169799585 ()


  • Orthopaedic implant driver
Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000953 ()
Reconstruction Planner

  • CAD/CAM software
Materialise Mimics Enlight CMF Orthognathic and Trauma Planner
Materialise NV
Orthognathic and Trauma Planner
In Commercial Distribution

  • 05404028000946 ()
Orthognathic and Trauma Planner

  • CAD/CAM software
Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000816 ()
Reconstruction Planner

  • CAD/CAM software
Mimics Enlight CMF Orthognathic Planner
Materialise NV
Orthognathic Planner
In Commercial Distribution

  • 05404028000809 ()
Orthognathic Planner

  • CAD/CAM software
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