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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ExFeel External C=1
Megagen Implant Co. Ltd
RDE100
In Commercial Distribution

  • 08806388231447 ()
RDE100T

  • Dental implant suprastructure, permanent, preformed
ExFeel External Ø5/ Hex
Megagen Implant Co. Ltd
RCA900
In Commercial Distribution

  • 08806388230990 ()
RCA900T

  • Dental implant suprastructure, permanent, preformed
ExFeel External Ø5/ Non-Hex
Megagen Implant Co. Ltd
RCA800
In Commercial Distribution

  • 08806388230983 ()
RCA800T

  • Dental implant suprastructure, permanent, preformed
EXTERNAL FIXATOR REMOVAL PACK
MEDLINE INDUSTRIES, INC.
DYNDA2370
In Commercial Distribution

  • 10193489516814 ()
DYNDA2370

  • General surgical procedure kit, non-medicated, single-use
Single Chamber External Pacemaker
Oscor Inc.
5391
Not in Commercial Distribution

  • 00643169382978 ()
5391

  • External pacemaker, epicardial pacing
External Magnet in Case
Coaptech, Inc.
0010323
In Commercial Distribution

  • 10850026037132 ()
  • 00850026037135 ()
  • 00850026037142 ()
0010366

  • Ultrasound-guided gastrostomy system magnet
External Trial Stimulator (Refurbished)
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-5110R
In Commercial Distribution

  • 08714729837244 ()
SC-5110R

  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
SURGICAL BOX KIT EXTERNAL
SOADCO, S.L.
KIT EXTERNA
In Commercial Distribution

  • 08435451627407 ()
KIT EXTERNA

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
SURGICAL BOX KIT EXTERNAL
SOADCO, S.L.
KIT EXTERNA
In Commercial Distribution

  • 08435451617804 ()
KIT EXTERNA

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
SURGICAL BOX KIT EXTERNAL
SOADCO, S.L.
KIT EXTERNA
In Commercial Distribution

  • 08435451612151 ()
KIT EXTERNA

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
External Trial Stimulator 2
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
DB-5132-S
In Commercial Distribution

  • 08714729984474 ()


  • Deep brain electrical stimulation system
Screw Retaining External Driver
NEXUS SPINE, L.L.C.
820335
In Commercial Distribution

  • B6788203350 ()
  • B678820335 ()


  • Orthopaedic implantation sleeve, reusable
Screw Head Positioner, External
GLOBUS MEDICAL, INC.
6119.1075
In Commercial Distribution

  • 00889095172805 ()


  • Surgical drill guide, reusable
Plate Holder, External Grip
GLOBUS MEDICAL, INC.
6102.1000
In Commercial Distribution

  • 00889095169799 ()


  • Surgical implant/trial-implant/sizer holder, reusable
STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL
Ibramed Industria Brasileira de Equipamentos Medicos Eir
NEURODYN MULTIWAVE
Not in Commercial Distribution

  • 07898961579016 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
Single Chamber External Pacemaker
Oscor Inc.
PACE 101H
In Commercial Distribution

  • 00836559008859 ()
PACE 101H

  • External pacemaker, epicardial pacing
External Fixator Tray #6
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF94026
In Commercial Distribution

  • 00889797071871 ()
SEF94026

  • Instrument tray, reusable
External Fixator Tray #5
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF94025
In Commercial Distribution

  • 00889797071864 ()
SEF94025

  • Instrument tray, reusable
External Fixator Tray #4
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF94019
In Commercial Distribution

  • 00889797071543 ()
SEF94019

  • Instrument tray, reusable
External Fixator Tray #3
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF94018
In Commercial Distribution

  • 00889797071536 ()
SEF94018

  • Instrument tray, reusable
External Fixator Tray #2
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF94017
In Commercial Distribution

  • 00889797071499 ()
SEF94017

  • Instrument tray, reusable
External Fixator Tray #1
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF94016
In Commercial Distribution

  • 00889797071482 ()
SEF94016

  • Instrument tray, reusable
External Fixation Frame Positioner
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF99300
In Commercial Distribution

  • 00889797052917 ()
SEF99300

  • Orthopaedic implant aiming/guiding block, reusable
External Fixation Leg Support
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF99100
In Commercial Distribution

  • 00889797052894 ()
SEF99100

  • Orthopaedic implant aiming/guiding block, reusable
External Fixation Slot Plug
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF99000
In Commercial Distribution

  • 00889797052887 ()
SEF99000

  • Orthopaedic implant aiming/guiding block, reusable
External Fixation Wire Guide
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF92500
In Commercial Distribution

  • 00889797052733 ()

  • Long
SEF92500

  • Orthopaedic implant aiming/guiding block, reusable
External Fixation Wire Guide
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF92000
In Commercial Distribution

  • 00889797052726 ()

  • Short
SEF92000

  • Orthopaedic implant aiming/guiding block, reusable
External Fixation Open Wrench
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF90310
In Commercial Distribution

  • 00889797052719 ()

  • Size: 10mm
  • Angle: 90 degree
SEF90310

  • Surgical torque wrench, reusable
External Fixation Ratchet Wrench
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF90210
In Commercial Distribution

  • 00889797052672 ()

  • Size: 10mm
SEF90210

  • Surgical torque wrench, reusable
External Fixation Wire Tensioner
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF90000
In Commercial Distribution

  • 00889797052634 ()
SEF90000

  • Orthopaedic implant/instrument assembling device
External Fixator Tray #7
WRIGHT MEDICAL TECHNOLOGY, INC.
SEF94024
In Commercial Distribution

  • 00889797001571 ()
SEF94024

  • Instrument tray, reusable
External Magnet in Case
Coaptech, Inc.
0010080
In Commercial Distribution

  • 00860312001542 ()
  • 10860312001532 ()
  • 00860312001535 ()
0010090

  • Ultrasound-guided gastrostomy system magnet
ROBOTIC KNEE EXTERNAL- NONSTERILE
AMERICAN CONTRACT SYSTEMS, INC.
MDRE31B
In Commercial Distribution

  • 00191072099471 ()


  • General surgical procedure kit, non-medicated, single-use
MICROSTREAM Capnostream35 External Charger
ORIDION MEDICAL 1987 LTD.
PM35CHG
Not in Commercial Distribution

  • 10884521548404 ()


  • Noninvasive device battery charger
External Trial Stimulator (Refurbished)
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-5160R
In Commercial Distribution

  • 08714729978404 ()


  • Analgesic spinal cord electrical stimulation system
EXTERNAL BOLUS BUTTON ASSET
B. BRAUN MEDICAL INC.
8710988-99
In Commercial Distribution

  • 04046964958212 ()
8710988-99

  • Bedside syringe pump
Oncentra External Beam v4.5
Nucletron B.V.
Oncentra External Beam
In Commercial Distribution

  • 08717213038677 ()


  • Radiation therapy software
Counter Torque, MIS, External
Xtant Medical Holdings, Inc.
1505-002340
In Commercial Distribution

  • 00840311209033 ()


  • Orthopaedic counter-torque/rod-pushing instrument
ROBOTIC KNEE EXTERNAL- NONSTERILE
AMERICAN CONTRACT SYSTEMS, INC.
MDRE31C
In Commercial Distribution

  • 00191072198310 ()


  • General surgical procedure kit, non-medicated, single-use
Extractor, Screw, LH External
Implant Logistics, Inc.
ST519
In Commercial Distribution

  • D762ST5190 ()


  • Dental implant extractor
External Electrical Field Conductor
BIONESS INC.
ST2-5050
In Commercial Distribution

  • 00815962021464 ()


  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, extracorporeal
Stableloc External Fixator Kit
Acumed LLC
FX-4001-S
In Commercial Distribution

  • 10806378067372 ()


  • General internal orthopaedic fixation system implantation kit
TEMPLATE, EXTERNAL TRACKER, FIXATOR
Exactech, Inc.
521-40-14
In Commercial Distribution

  • 10885862252838 ()
521-40-14

  • Orthopaedic stereotactic surgery system
SLED, EXTERNAL TRACKER FIXATOR
Exactech, Inc.
521-99-03
In Commercial Distribution

  • 10885862092977 ()
521-99-03

  • Instrument tray, reusable
Oculocam external smartphone mount.
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
8100SPEX
In Commercial Distribution

  • B1778100SPEX0 ()


  • Surgical camera holder
External Pulse Transmitter (EPT)
BIONESS INC.
ST2-5000
In Commercial Distribution

  • 00815962020030 ()


  • Analgesic PENS system probe, single-use
External Drainage and Depression
Vortex Surgical, Inc.
Straight
In Commercial Distribution

  • B384VS0290 ()
VS0290

  • Vitrectomy fluid/gas handling handpiece/cannula
Drill ø5.50mm External Irrigation
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118144359 ()
TD1-0010

  • Dental implant system
Drill ø5mm External Irrigation
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118144342 ()
TD1-0009

  • Dental implant system
Drill ø4.50mm External Irrigation
NOGA MEDICAL PRODUCTS LTD
A
In Commercial Distribution

  • 07290118144335 ()
TD1-0008

  • Dental implant system
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