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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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Ergon Boom Series - 10841736100858

"Q" Dual Radial Arm Set
SKYTRON LLC
Ergon 3
In Commercial Distribution

  • 10841736100858 ()
200 Series

  • General utility supply system, ceiling-mounted

Ergon Boom Series - 10841736100650

Q Dual Radial Arm Set
SKYTRON LLC
Ergon 2
In Commercial Distribution

  • 10841736100650 ()
E2 200 Series

  • General utility supply system, ceiling-mounted

N/A - 07613327576542

Stryker Ortho Q Guidance System
Stryker Leibinger GmbH & Co. KG
8800-100-000
In Commercial Distribution

  • 07613327576542 ()
8800-100-000

  • Optical surgical navigation device tracking system

NA - 00842307100348

WHEELCHAIR,26X20DP,REM ARM,Q/
GENDRON, INC.
6826-20-62-27-84-8
Not in Commercial Distribution

  • 00842307100348 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

Viper II Apical Lift - 00899054002548

Apical Lift Positioner, Q Base
KDL MEDICAL, INC.
API-800VS
In Commercial Distribution

  • 00899054002548 ()


  • Patient positioning vacuum pad

Viper II Heart Stabilizer - 00899054002500

Heart Stabilizer, Vacuum, Q Base
KDL MEDICAL, INC.
STB-800VS
In Commercial Distribution

  • 00899054002500 ()


  • Patient positioning vacuum pad

Molded Products, Inc. - B144MPC700VI1

Barrier Adapter with Q Seal
MOLDED PRODUCTS, INC.
MPC-700-VI
In Commercial Distribution

  • B144MPC700VI3 ()
  • B144MPC700VI1 ()
  • B144MPC700VI0 ()
MPC-700-VI

  • Hollow-fibre haemodialysis dialyser, reusable

Molded Products, Inc. - B144MPC7001

Barrier Adapter with Q Seal
MOLDED PRODUCTS, INC.
MPC-700
In Commercial Distribution

  • B144MPC7003 ()
  • B144MPC7001 ()
  • B144MPC7000 ()
MPC-700

  • Hollow-fibre haemodialysis dialyser, reusable

NA - 00763000245917

CUSTOM PACK HY10V39R3 PEDI Q
MEDTRONIC, INC.
HY10V39R3
In Commercial Distribution

  • 00763000245917 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00763000976415

CUSTOM PACK BB10V39R5 PEDI Q
MEDTRONIC, INC.
BB10V39R5
In Commercial Distribution

  • 00763000976415 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00763000639044

CUSTOM PACK HY10V39R4 PEDI Q
MEDTRONIC, INC.
HY10V39R4
In Commercial Distribution

  • 00763000639044 ()


  • Cardiopulmonary bypass system blood tubing set

NA - 00763000455644

CUSTOM PACK CB11F34R1 Q PLEGIA
MEDTRONIC, INC.
CB11F34R1
In Commercial Distribution

  • 00763000455644 ()


  • Cardiopulmonary bypass system blood tubing set

OrthoMedFlex, LLC - M7161011430

Q/C Stem Extractor/Impactor
ORTHOMEDFLEX LLC
101-143
In Commercial Distribution

  • M7161011430 ()
101-143

  • Orthopaedic implant impactor, reusable

QuarkBio® - 04719890680020

Q Station™ Dx 1000
QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)
Q Station
In Commercial Distribution

  • 04719890680020 ()
QST-Dx1000-2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

QuarkBio® - 04719890680013

Q Station™ Dx 1000
QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)
Q Station
In Commercial Distribution

  • 04719890680013 ()
QST-Dx1000-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Pilot Laser Overfit-Style Glasses - 00872320003517

Laser protective eyewear for use with the Pilot Diode Laser.
CAO GROUP, INC.
002-00360
In Commercial Distribution

  • 00872320003517 ()
002-00360

  • Radiation shielding goggles/spectacles

Pilot Laser Sport-Style Glasses - 00872320003500

Laser protective eyewear for use with the Pilot Diode Laser.
CAO GROUP, INC.
002-00359
In Commercial Distribution

  • 00872320003500 ()
002-00359

  • Radiation shielding goggles/spectacles

Precise Lasers Overfit-Style Glasses - 00872320003494

Laser protective eyewear for use with the Precise family of diode lasers.
CAO GROUP, INC.
002-00268
In Commercial Distribution

  • 00872320003494 ()
002-00268

  • Radiation shielding goggles/spectacles

Precise Laser Sport-Style Glasses - 00872320003487

Laser protective eyewear for use with the Precise family of diode lasers.
CAO GROUP, INC.
002-00267
In Commercial Distribution

  • 00872320003487 ()
002-00267

  • Radiation shielding goggles/spectacles

Pioneer Laser Laser Protective Glasses - 00872320002459

Laser protective eyewear for use with the Pioneer family of diode lasers.
CAO GROUP, INC.
002-00275
In Commercial Distribution

  • 00872320002459 ()
002-00275

  • Radiation shielding goggles/spectacles

Monet Curing Laser Small Glasses - 00872320005641

Small laser protective glasses for use with the Monet Curing Laser.
CAO GROUP, INC.
001-00108
In Commercial Distribution

  • 00872320005641 ()


  • Radiation shielding goggles/spectacles

Monet Curing Laser Large Glasses - 00872320005634

Large laser protective glasses for use with the Monet Curing Laser.
CAO GROUP, INC.
001-00107
In Commercial Distribution

  • 00872320005634 ()


  • Radiation shielding goggles/spectacles

Ease-In-Shields - 00883205037558

CO2 Ease-In-Shields OT Light Scalpel
ULTRADENT PRODUCTS, INC.
5847
In Commercial Distribution

  • 00883205037558 ()
5847

  • Radiation shielding goggles/spectacles

Ease-In-Shields - 00883205037541

NDYAG and ERYAG Ease-In-Shields
ULTRADENT PRODUCTS, INC.
5846
In Commercial Distribution

  • 00883205037541 ()
5846

  • Radiation shielding goggles/spectacles

Ease-In-Shields - 00883205037534

TriWave Ease-In-Shields
ULTRADENT PRODUCTS, INC.
5845
In Commercial Distribution

  • 00883205037534 ()
5845

  • Radiation shielding goggles/spectacles

Ease-In-Shields - 00883205037527

CO2 Ease-In-Shields
ULTRADENT PRODUCTS, INC.
5844
In Commercial Distribution

  • 00883205037527 ()
5844

  • Radiation shielding goggles/spectacles

Ease-In-Shields - 00883205037510

Pink Diode Soft Tissue Edition Ease-In-Shields
ULTRADENT PRODUCTS, INC.
5843
In Commercial Distribution

  • 00883205037510 ()
5843

  • Radiation shielding goggles/spectacles

Ease-In-Shields - 00883205037503

Multi-Wave Ease-In-Shields
ULTRADENT PRODUCTS, INC.
5842
In Commercial Distribution

  • 00883205037503 ()
5842

  • Radiation shielding goggles/spectacles

Ease-In-Shields - 00883205037497

Industrial/ R&D Edition Ease-In-Shields
ULTRADENT PRODUCTS, INC.
5841
In Commercial Distribution

  • 00883205037497 ()
5841

  • Radiation shielding goggles/spectacles

Ease-In-Shields - 00883205037480

Aviation Ease-In-Shields
ULTRADENT PRODUCTS, INC.
5840
In Commercial Distribution

  • 00883205037480 ()
5840

  • Radiation shielding goggles/spectacles

Ease-In-Shields - 00883205037473

Curing Light Ease-In-Shields
ULTRADENT PRODUCTS, INC.
5839
In Commercial Distribution

  • 00883205037473 ()
5839

  • Radiation shielding goggles/spectacles

Ease-In-Shields - 00883205037466

Diode Soft Tissue Ease-In-Shields
ULTRADENT PRODUCTS, INC.
5838
In Commercial Distribution

  • 00883205037466 ()
5838

  • Radiation shielding goggles/spectacles

Ease-In-Shields - 00883205037459

Dual Wave Ease-In-Shields
ULTRADENT PRODUCTS, INC.
5837
In Commercial Distribution

  • 00883205037459 ()
5837

  • Radiation shielding goggles/spectacles

Ease-In-Shields - 00883205037442

CO2 Ease-In-Shields
ULTRADENT PRODUCTS, INC.
5836
In Commercial Distribution

  • 00883205037442 ()
5836

  • Radiation shielding goggles/spectacles

Ease-In-Shields - 00883205037435

Universal Hard Tissue Ease-in-Shields
ULTRADENT PRODUCTS, INC.
5835
In Commercial Distribution

  • 00883205037435 ()
5835

  • Radiation shielding goggles/spectacles

Ease-In-Shields - 00883205037428

Universal Soft Tissue Ease-in-Shields
ULTRADENT PRODUCTS, INC.
5832
In Commercial Distribution

  • 00883205037428 ()
5832

  • Radiation shielding goggles/spectacles

Oakley Fuel Cell Radiation Protection Glasses - 00860004894612

Oakley Fuel Cell X-Ray Safety Radiation Protection Glasses with Corning® Med-X® Glass 0.75mm Pb
Barrier Technologies, LLC
BT000B2991
In Commercial Distribution

  • 00860004894612 ()


  • Radiation shielding goggles/spectacles

Laser Safety Goggles (fit-over frame) - 00851759007174

Laser Safety Sport Fit-Over Goggle, OD 5+ @ 800nm-820nm EN207: 800-820 DIR LB5 PF w/ Box and Lanyard
AMD Lasers
EYEF
Not in Commercial Distribution

  • 00851759007174 ()
EYEF

  • Radiation shielding goggles/spectacles

Laser Safety Goggles (Sport Frame) - 00851759007167

Laser Safety Sport Goggle, OD 5+ @ 800nm-820nm EN207: 800-820 DIR LB5 PF w/ Box and Lanyard
AMD Lasers
EYE
Not in Commercial Distribution

  • 00851759007167 ()
EYE

  • Radiation shielding goggles/spectacles

Barrier Lite-Bifocal-Radiation Protection Glasses - 00850035588376

Barrier Lite-Bifocal-Radiation Protection Glasses
Barrier Technologies, LLC
BLT-BF
In Commercial Distribution

  • 00850035588376 ()


  • Radiation shielding goggles/spectacles

Astro II-w/side shields-Blue-Radiation Protection Glasses - 00850035588369

Astro II-w/side shields-Blue-Radiation Protection Glasses
Barrier Technologies, LLC
ASTS II-BLU
In Commercial Distribution

  • 00850035588369 ()


  • Radiation shielding goggles/spectacles

Astro II-Bifocal-Radiation Protection Glasses - 00850035588352

Astro II-Bifocal-Radiation Protection Glasses
Barrier Technologies, LLC
AST II-BF
In Commercial Distribution

  • 00850035588352 ()


  • Radiation shielding goggles/spectacles

Armourx-w/side shields-Black-Radiation Protection Glasses - 00850035588345

Armourx-w/side shields-Black-Radiation Protection Glasses
Barrier Technologies, LLC
ArmouRx-9-B
In Commercial Distribution

  • 00850035588345 ()


  • Radiation shielding goggles/spectacles

Armourx-Bifocal-Radiation Protection Glasses - 00850035588338

Armourx-Bifocal-Radiation Protection Glasses
Barrier Technologies, LLC
ARX-BF
In Commercial Distribution

  • 00850035588338 ()


  • Radiation shielding goggles/spectacles

CROSSLINK-B - CROSSLINK - SATIN BLACK - RADIATION PROTECTION GLASSES - 00850035588277

CROSSLINK-B - CROSSLINK - SATIN BLACK - RADIATION PROTECTION GLASSES
Barrier Technologies, LLC
Crosslink-B
In Commercial Distribution

  • 00850035588277 ()


  • Radiation shielding goggles/spectacles

CIRCUIT - BLACK- RADIATION PROTECTION GLASSES - 00850035588260

CIRCUIT - BLACK- RADIATION PROTECTION GLASSES
Barrier Technologies, LLC
CIRC-B
In Commercial Distribution

  • 00850035588260 ()


  • Radiation shielding goggles/spectacles

BLT-B - BARRIER LITE - BLACK- RADIATION PROTECTION GLASSES - 00850035588253

BARRIER LITE - BLACK- RADIATION PROTECTION GLASSES
Barrier Technologies, LLC
BLT-B
In Commercial Distribution

  • 00850035588253 ()


  • Radiation shielding goggles/spectacles

ARX-B - ARMOURX -BLACK- RADIATION PROTECTION GLASSES - 00850035588246

ARMOURX -BLACK- RADIATION PROTECTION GLASSES
Barrier Technologies, LLC
ARX-B
In Commercial Distribution

  • 00850035588246 ()


  • Radiation shielding goggles/spectacles

Astro Radiation Protection Glasses - 00850035588239

ASTRO DLX-R - ASTRO DLX - W/SIDE SHIELDS - RED/BLACK - RADIATION PROTECTION GLASSES
Barrier Technologies, LLC
Astro DLX-R
In Commercial Distribution

  • 00850035588239 ()


  • Radiation shielding goggles/spectacles

Opti-Gard - 10850017419077

LASER OPTI-GARD LARGE NON-STERILE PACK
DUPACO, INC.
D28400
In Commercial Distribution

  • 00850017419070 ()
  • 10850017419077 ()
D28400

  • Radiation shielding goggles/spectacles
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