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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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X-Guide - 00817421020520

X-CLIP
XNAV TECHNOLOGIES LLC
P007665
In Commercial Distribution

  • 00817421020520 ()
  • 00817421020582 ()
  • 00817421020605 ()
P007665

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020513

BASELINE CALIBRATION PLATE
XNAV TECHNOLOGIES LLC
P008810
In Commercial Distribution

  • 00817421020513 ()
P008810

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020506

SAFETY GLASSES
XNAV TECHNOLOGIES LLC
P008395
In Commercial Distribution

  • 00817421020506 ()
P008395

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020490

HANDPIECE CONNECTOR ASM. - W&H
XNAV TECHNOLOGIES LLC
P008796
In Commercial Distribution

  • 00817421020490 ()
P008796

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020483

HANDPIECE CONNECTOR ASM. - NOUVAG
XNAV TECHNOLOGIES LLC
P007645
In Commercial Distribution

  • 00817421020483 ()
P007645

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020476

HANDPIECE ASSEMBLY TOOL
XNAV TECHNOLOGIES LLC
P009229
In Commercial Distribution

  • 00817421020476 ()
P009229

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020452

BONE SCREW - 2.7Ø x 10mm
XNAV TECHNOLOGIES LLC
P007739
In Commercial Distribution

  • 00817421020452 ()
  • 00817421020469 ()
  • 00817421023026 ()
P007739

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020438

BONE SCREW - 2.7Ø x 8mm
XNAV TECHNOLOGIES LLC
P007738
In Commercial Distribution

  • 00817421020438 ()
  • 00817421020445 ()
  • 00817421023019 ()
P007738

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020414

BONE SCREW - 2.7Ø x 6mm
XNAV TECHNOLOGIES LLC
P007737
In Commercial Distribution

  • 00817421020414 ()
  • 00817421020421 ()
  • 00817421023002 ()
P007737

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020391

BONE SCREW - 2.7Ø x 4mm
XNAV TECHNOLOGIES LLC
P007736
In Commercial Distribution

  • 00817421020391 ()
  • 00817421020407 ()
  • 00817421022999 ()
P007736

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020377

BONE SCREW - 2.0Ø x 10mm
XNAV TECHNOLOGIES LLC
P007464
In Commercial Distribution

  • 00817421020377 ()
  • 00817421020384 ()
  • 00817421022982 ()
P007464

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020353

BONE SCREW - 2.0Ø x 8mm
XNAV TECHNOLOGIES LLC
P007463
In Commercial Distribution

  • 00817421020353 ()
  • 00817421020360 ()
  • 00817421022975 ()
P007463

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020339

BONE SCREW - 2.0Ø x 6mm
XNAV TECHNOLOGIES LLC
P007462
In Commercial Distribution

  • 00817421020339 ()
  • 00817421020346 ()
  • 00817421022968 ()
P007462

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020315

BONE SCREW - 2.0Ø x 4mm
XNAV TECHNOLOGIES LLC
P007461
In Commercial Distribution

  • 00817421020315 ()
  • 00817421020322 ()
  • 00817421022951 ()
P007461

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020292

EDENTULOUS CLIP - NO SPIKES
XNAV TECHNOLOGIES LLC
P007750
In Commercial Distribution

  • 00817421020292 ()
  • 00817421020308 ()
P007750

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020278

EDENTULOUS CLIP
XNAV TECHNOLOGIES LLC
P007749
In Commercial Distribution

  • 00817421020278 ()
  • 00817421020285 ()
P007749

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020261

EDENTULOUS KIT
XNAV TECHNOLOGIES LLC
P008819
In Commercial Distribution

  • 00817421020261 ()
P008819

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020254

STRAIGHT HANDPIECE CALIBRATION BIT
XNAV TECHNOLOGIES LLC
P009311
In Commercial Distribution

  • 00817421020254 ()
P009311

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020247

WRENCH
XNAV TECHNOLOGIES LLC
P009154
In Commercial Distribution

  • 00817421020247 ()
P009154

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020230

PROBE TOOL
XNAV TECHNOLOGIES LLC
P008886
In Commercial Distribution

  • 00817421020230 ()
P008886

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020223

SCREW DRIVER
XNAV TECHNOLOGIES LLC
P007842
In Commercial Distribution

  • 00817421020223 ()
P007842

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020216

TRACKER ARM - LEFT
XNAV TECHNOLOGIES LLC
P008802
Not in Commercial Distribution

  • 00817421020216 ()
P008802

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020209

TRACKER ARM - RIGHT
XNAV TECHNOLOGIES LLC
P008800
Not in Commercial Distribution

  • 00817421020209 ()
P008800

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020193

TRACKER ARM - UNIVERSAL
XNAV TECHNOLOGIES LLC
P007505
In Commercial Distribution

  • 00817421020193 ()
P007505

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020186

HANDPIECE CALIBRATION DISC
XNAV TECHNOLOGIES LLC
P007747
In Commercial Distribution

  • 00817421020186 ()
P007747

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020179

GO PLATE
XNAV TECHNOLOGIES LLC
P008641
In Commercial Distribution

  • 00817421020179 ()
P008641

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020162

PATIENT TRACKER
XNAV TECHNOLOGIES LLC
P007652
In Commercial Distribution

  • 00817421020162 ()
P007652

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020155

PROBE TOOL TRACKER
XNAV TECHNOLOGIES LLC
P009181
In Commercial Distribution

  • 00817421020155 ()
P009181

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020148

HANDPIECE TRACKER
XNAV TECHNOLOGIES LLC
P007640
In Commercial Distribution

  • 00817421020148 ()
P007640

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020131

INSTRUMENT KIT
XNAV TECHNOLOGIES LLC
P008818
In Commercial Distribution

  • 00817421020131 ()
P008818

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020124

X-CLIP - PRACTICE
XNAV TECHNOLOGIES LLC
P007793
In Commercial Distribution

  • 00817421020124 ()
  • 00817421020544 ()
P007793

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020117

X-GUIDE TRAINING KIT
XNAV TECHNOLOGIES LLC
P008930
In Commercial Distribution

  • 00817421020117 ()
P008930

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020100

X-GUIDE USER MANUAL, ENGLISH
XNAV TECHNOLOGIES LLC
P007593
In Commercial Distribution

  • 00817421020100 ()
P007593

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020070

X-GUIDE REGION KIT - U.K. / IRELAND, ENGLISH
XNAV TECHNOLOGIES LLC
P009137
Not in Commercial Distribution

  • 00817421020070 ()
P009137

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020063

X-GUIDE REGION KIT - NORTH AMERICA, ENGLISH
XNAV TECHNOLOGIES LLC
P009081
In Commercial Distribution

  • 00817421020063 ()
P009081

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020056

CART TRAY KIT
XNAV TECHNOLOGIES LLC
P009186
In Commercial Distribution

  • 00817421020056 ()
P009186

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020025

X-GUIDE (United States)
XNAV TECHNOLOGIES LLC
P007839
In Commercial Distribution

  • 00817421020025 ()
  • 00817421022074 ()
P007839

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020018

X-GUIDE PLANNING SOFTWARE - MAC OS
XNAV TECHNOLOGIES LLC
P008526
In Commercial Distribution

  • 00817421020018 ()
P008526

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020001

X-GUIDE PLANNING SOFTWARE - MS WINDOWS
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421020001 ()
P008296

  • Surgical planning/navigation-enhancement system

Portable X-Ray System - 00817100020353

Portable X-Ray System-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR301
In Commercial Distribution

  • 00817100020353 ()


  • Portable basic diagnostic x-ray system, digital

Portable X-Ray System - 00817100020124

SR-130 + DR Portable VIZION M portavle X-Ray System (100kV/30mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR310
In Commercial Distribution

  • 00817100020124 ()


  • Portable basic diagnostic x-ray system, digital

Portable X-Ray System - 00817100020117

SR-130 + DR Portable X-Ray System (100kV/30mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR300
In Commercial Distribution

  • 00817100020117 ()


  • Portable basic diagnostic x-ray system, digital

SPINEMAP - 07613327359985

SPINEMAP¿ 3D 3.1 - UPGRADE
Stryker Leibinger GmbH & Co. KG
6002-680-100
In Commercial Distribution

  • 07613327359985 ()
6002-680-100

  • Surgical planning/navigation-enhancement system

SPINEMAP - 07613327359978

SPINEMAP¿ 3D 3.1 - ENABLE
Stryker Leibinger GmbH & Co. KG
6002-680-300
In Commercial Distribution

  • 07613327359978 ()
6002-680-300

  • Surgical planning/navigation-enhancement system

SPINEMAP - 07613327359961

SPINEMAP¿ 3D 3.1 - SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81039
In Commercial Distribution

  • 07613327359961 ()
81-81039

  • Surgical planning/navigation-enhancement system

SPINEMAP - 07613327359954

SPINEMAP¿ 3D 3.1 - SOFTWARE
Stryker Leibinger GmbH & Co. KG
6002-680-000
In Commercial Distribution

  • 07613327359954 ()
6002-680-000

  • Surgical planning/navigation-enhancement system

Q-Tel RMS - 00812345029888

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
33193-104-50
Not in Commercial Distribution

  • 00812345029888 ()


  • Centralized patient monitor

Q-Tel RMS - 00812345029871

Cardiac and pulmonary rehabilitation data acquisition and editing system
MORTARA INSTRUMENT, INC.
33193-103-50
Not in Commercial Distribution

  • 00812345029871 ()


  • Centralized patient monitor

Surveyor S19 - 00812345029864

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR19-BAA-XXAAX
Not in Commercial Distribution

  • 00812345029864 ()


  • Centralized patient monitor

Surveyor S12 - 00812345029833

Patient Monitor
MORTARA INSTRUMENT, INC.
SUR12-JDG-BXAAX
Not in Commercial Distribution

  • 00812345029833 ()


  • Centralized patient monitor
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