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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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Medtronic Navigation - 00763000456832

SFW KIT 9735929 STEALTHVIZ S8 DEMO EU-E
MEDTRONIC NAVIGATION, INC.
9735929
In Commercial Distribution

  • 00763000456832 ()


  • Neurological stereotactic surgery system

Medtronic Navigation - 00763000456818

SW KT 9735900 STEALTHVIZ S8 60DAY EU-SW
MEDTRONIC NAVIGATION, INC.
9735900
In Commercial Distribution

  • 00763000456818 ()


  • Neurological stereotactic surgery system

Medtronic Navigation - 00763000456795

SW KT 9735900 STEALTHVIZ S8 60DAY EU-SD
MEDTRONIC NAVIGATION, INC.
9735900
In Commercial Distribution

  • 00763000456795 ()


  • Neurological stereotactic surgery system

Medtronic Navigation - 00763000456788

SW KT 9735900 STEALTHVIZ S8 60DAY EU-NW
MEDTRONIC NAVIGATION, INC.
9735900
In Commercial Distribution

  • 00763000456788 ()


  • Neurological stereotactic surgery system

Medtronic Navigation - 00763000456771

SW KT 9735900 STEALTHVIZ S8 60DAY EU-E
MEDTRONIC NAVIGATION, INC.
9735900
In Commercial Distribution

  • 00763000456771 ()


  • Neurological stereotactic surgery system

Medtronic Navigation - 00763000456764

SFW KIT 9735900 STEALTHVIZ S8 60DAY
MEDTRONIC NAVIGATION, INC.
9735900
In Commercial Distribution

  • 00763000456764 ()


  • Neurological stereotactic surgery system

Medtronic Navigation - 00763000456757

SW KT 9735899 STEALTHVIZ S8 MULTI EU-SW
MEDTRONIC NAVIGATION, INC.
9735899
In Commercial Distribution

  • 00763000456757 ()


  • Neurological stereotactic surgery system

Medtronic Navigation - 00763000456740

SW KT 9735899 STEALTHVIZ S8 MULTI EU-SE
MEDTRONIC NAVIGATION, INC.
9735899
In Commercial Distribution

  • 00763000456740 ()


  • Neurological stereotactic surgery system

Medtronic Navigation - 00763000456733

SW KT 9735899 STEALTHVIZ S8 MULTI EU-SD
MEDTRONIC NAVIGATION, INC.
9735899
In Commercial Distribution

  • 00763000456733 ()


  • Neurological stereotactic surgery system

Medtronic Navigation - 00763000456726

SW KT 9735899 STEALTHVIZ S8 MULTI EU-NW
MEDTRONIC NAVIGATION, INC.
9735899
In Commercial Distribution

  • 00763000456726 ()


  • Neurological stereotactic surgery system

Medtronic Navigation - 00763000456719

SW KT 9735899 STEALTHVIZ S8 MULTI EU-E
MEDTRONIC NAVIGATION, INC.
9735899
In Commercial Distribution

  • 00763000456719 ()


  • Neurological stereotactic surgery system

Medtronic Navigation - 00763000456702

SFW KIT 9735899 STEALTHVIZ S8 MULTI
MEDTRONIC NAVIGATION, INC.
9735899
In Commercial Distribution

  • 00763000456702 ()


  • Neurological stereotactic surgery system

Medtronic Navigation - 00763000456696

SW KT 9735898 STEALTHVIZ W DTI S8 EU-SW
MEDTRONIC NAVIGATION, INC.
9735898
In Commercial Distribution

  • 00763000456696 ()


  • Neurological stereotactic surgery system

Medtronic Navigation - 00763000456689

SW KT 9735898 STEALTHVIZ W DTI S8 EU-SE
MEDTRONIC NAVIGATION, INC.
9735898
In Commercial Distribution

  • 00763000456689 ()


  • Neurological stereotactic surgery system

Medtronic Navigation - 00763000456672

SW KT 9735898 STEALTHVIZ W DTI S8 EU-SD
MEDTRONIC NAVIGATION, INC.
9735898
In Commercial Distribution

  • 00763000456672 ()


  • Neurological stereotactic surgery system

Unimed - 06945664882064

One piece ECG Monitor Cable/Medtronic Socket/4-lead/Snap/AHA/1.7M+1.0M*2+1.3M*2/541/Coast Biomedical Equipment
Unimed Medical Supplies, Inc.
C415-0064N
In Commercial Distribution

  • 06945664882064 ()


  • Electrocardiographic lead set, reusable

Unimed - 06945664881821

One piece ECG Monitor Cable/Medtronic Socke/4-lead/grabber/AHA/1.7M+1.0M*2+1.3M*2/541/Coast Biomedical Equipment
Unimed Medical Supplies, Inc.
C415-0064
In Commercial Distribution

  • 06945664881821 ()


  • Electrocardiographic lead set, reusable

CarboClear Pedicle Screw System - 07290110208516

Navigated Bone Tap for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System.
CARBOFIX ORTHOPEDICS LTD
Navigated Tap 4.5mm
In Commercial Distribution

  • 07290110208516 ()

  • Outer Diameter: 4.5 Millimeter
PPS922770N

  • Bone tap, reusable

CarboClear Pedicle Screw System - 07290110208509

Navigated Bone Tap for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System.
CARBOFIX ORTHOPEDICS LTD
Navigated Tap 5.0mm
In Commercial Distribution

  • 07290110208509 ()

  • Outer Diameter: 5.0 Millimeter
PPS922760N

  • Bone tap, reusable

CarboClear Pedicle Screw System - 07290110208493

Navigated Bone Tap for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System.
CARBOFIX ORTHOPEDICS LTD
Navigated Tap 5.5mm
In Commercial Distribution

  • 07290110208493 ()

  • Outer Diameter: 5.5 Millimeter
PPS922750N

  • Bone tap, reusable

CarboClear Pedicle Screw System - 07290110208486

Navigated Bone Tap for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System.
CARBOFIX ORTHOPEDICS LTD
Navigated Tap 6.0mm
In Commercial Distribution

  • 07290110208486 ()

  • Outer Diameter: 6.0 Millimeter
PPS922740N

  • Bone tap, reusable

CarboClear Pedicle Screw System - 07290110208479

Navigated Bone Tap for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System.
CARBOFIX ORTHOPEDICS LTD
Navigated Tap 6.5mm
In Commercial Distribution

  • 07290110208479 ()

  • Outer Diameter: 6.5 Millimeter
PPS922730N

  • Bone tap, reusable

CarboClear Pedicle Screw System - 07290110208462

Navigated Bone Tap for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System.
CARBOFIX ORTHOPEDICS LTD
Navigated Tap 7.0mm
In Commercial Distribution

  • 07290110208462 ()

  • Outer Diameter: 7.0 Millimeter
PPS922720N

  • Bone tap, reusable

CarboClear Pedicle Screw System - 07290110208455

Navigated Bone Tap for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System.
CARBOFIX ORTHOPEDICS LTD
Navigated Tap 7.5mm
In Commercial Distribution

  • 07290110208455 ()

  • Outer Diameter: 7.5 Millimeter
PPS922710N

  • Bone tap, reusable

CarboClear Pedicle Screw System - 07290110208448

Navigated Pedicle Probe for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System.
CARBOFIX ORTHOPEDICS LTD
Navigated Probe - Pointed, Straight
In Commercial Distribution

  • 07290110208448 ()
PPS922650N

  • General internal orthopaedic fixation system implantation kit

CarboClear Pedicle Screw System - 07290110208400

Navigated Pedicle Probe for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System.
CARBOFIX ORTHOPEDICS LTD
Navigated Probe - Blunt, Straight
In Commercial Distribution

  • 07290110208400 ()
PPS922120N

  • General internal orthopaedic fixation system implantation kit

MEDTRONIC FHC MICRODRIVE HOLDER - 03760244030108

MEDTRONIC FHC MICRODRIVE HOLDER (V2) instrument Rosa 3.0 mechanical holder for FHC DBS microdrive, supplied with M5 x 10 wing nut
MEDTECH
ROSA-282C
Not in Commercial Distribution

  • 03760244030108 ()
ROSAS00018

  • Neurological stereotactic surgery system

IEM GmbH - 04041346102054

Hypertension Management Software
IEM GmbH
HMS CS 6.1.3 Medtronic 1.0.0
In Commercial Distribution

  • 04041346102054 ()


  • Medical equipment clinical data interfacing software

CarboClear Pedicle Screw System - 07290110208417

Navigated Pedicle Screw Screwdriver for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System.
CARBOFIX ORTHOPEDICS LTD
Navigated Screwdriver
In Commercial Distribution

  • 07290110208417 ()
PPS922160N

  • Surgical screwdriver, reusable

FloProbe 3/8’’ x 3/8” (Non Sterile) - 10814321020176

The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.
Movair, Inc.
3080N
Not in Commercial Distribution

  • 10814321020176 ()
  • 00814321020179 ()


  • Electromagnetic blood flowmeter

FloProbe 1/4’’ x 1/4" (Non Sterile) - 10814321020152

The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38P.
Movair, Inc.
3090N
Not in Commercial Distribution

  • 10814321020152 ()
  • 00814321020155 ()


  • Electromagnetic blood flowmeter

FloProbe 3/8" x 3/8” (Sterile) - 00814321020186

The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.
Movair, Inc.
3080S
Not in Commercial Distribution

  • 00814321020186 ()


  • Electromagnetic blood flowmeter

FloProbe 1/4’’ x 1/4’’ (Sterile) - 00814321020162

The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38P.
Movair, Inc.
3090S
Not in Commercial Distribution

  • 00814321020162 ()


  • Electromagnetic blood flowmeter

Medtronic Reusable Instruments - 00613994245144

INSTRUMENT X1103505 BAYONETD SUTRE PSHR
MEDTRONIC SOFAMOR DANEK, INC.
X1103505
In Commercial Distribution

  • 00613994245144 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable

Medtronic Reusable Instruments - 00613994245137

INSTRUMENT X1103506 BAYONETD FORCPS SHRP
MEDTRONIC SOFAMOR DANEK, INC.
X1103506
In Commercial Distribution

  • 00613994245137 ()


  • Bone distraction forceps

Medtronic Reusable Instruments - 00613994245120

INSTRUMENT X1103512 BAYONETD HK SHRP 3MM
MEDTRONIC SOFAMOR DANEK, INC.
X1103512
In Commercial Distribution

  • 00613994245120 ()


  • Orthopaedic instrument surgical connector

Medtronic Reusable Instruments - 00613994245113

INSTRUMENT X1103513 BAYONETD WOODSN PRB
MEDTRONIC SOFAMOR DANEK, INC.
X1103513
In Commercial Distribution

  • 00613994245113 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable

Medtronic Reusable Instruments - 00613994236159

DRIVER 7576310 QC REDUCTION NUT DRVR
MEDTRONIC SOFAMOR DANEK, INC.
7576310
In Commercial Distribution

  • 00613994236159 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00613994235473

CASE 7870136 H A COATED SCREWS SUITCASE
MEDTRONIC SOFAMOR DANEK, INC.
7870136
In Commercial Distribution

  • 00613994235473 ()


  • Instrument tray, reusable

Medtronic Reusable Instruments - 00613994230676

PROBE X0706141 PROBE
MEDTRONIC SOFAMOR DANEK, INC.
X0706141
In Commercial Distribution

  • 00613994230676 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
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