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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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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

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

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

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

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

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

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

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

Plasdent - D832S69010

Genesis Replacement Lenses, Gray
PLASDENT CORPORATION
S6901
In Commercial Distribution

  • D832S69010 ()
S6901

  • Radiation shielding goggles/spectacles

Plasdent - D832S6900X0

Genesis Replacement Lenses, Clear
PLASDENT CORPORATION
S6900X
In Commercial Distribution

  • D832S6900X0 ()
S6900X

  • Radiation shielding goggles/spectacles

Plasdent - D832S63120

Bandit Replacement Lenses, Gray
PLASDENT CORPORATION
S6312
In Commercial Distribution

  • D832S63120 ()
S6312

  • Radiation shielding goggles/spectacles

Plasdent - D832S535C0

Astro-spec 3000 Replacement Lenses, Clear
PLASDENT CORPORATION
S535C
In Commercial Distribution

  • D832S535C0 ()
S535C

  • Radiation shielding goggles/spectacles

Plasdent - D832S3240X0

Genesis, Blue/Clear
PLASDENT CORPORATION
S3240X
In Commercial Distribution

  • D832S3240X0 ()
S3240X

  • Radiation shielding goggles/spectacles

Plasdent - D832S1600X0

Bandit, Black/Clear
PLASDENT CORPORATION
S1600X
In Commercial Distribution

  • D832S1600X0 ()
S1600X

  • Radiation shielding goggles/spectacles

Plasdent - D832S135C0

Astro-spec 3000, Black/Clear
PLASDENT CORPORATION
S135C
In Commercial Distribution

  • D832S135C0 ()
S135C

  • Radiation shielding goggles/spectacles

Plasdent - D832S129C0

Astro-spec 3000, Blue/Clear
PLASDENT CORPORATION
S129C
In Commercial Distribution

  • D832S129C0 ()
S129C

  • Radiation shielding goggles/spectacles

Plasdent - D832S5360

Astro-spec 3000 Replacement Lenses, Gray
PLASDENT CORPORATION
S536
In Commercial Distribution

  • D832S5360 ()
S536

  • Radiation shielding goggles/spectacles

Plasdent - D832S3200X0

Genesis, Black/Clear
PLASDENT CORPORATION
S3200X
In Commercial Distribution

  • D832S3200X0 ()
S3200X

  • Radiation shielding goggles/spectacles

Plasdent - D832S0360X0

Ultra-spec 2000, Orange Lenses
PLASDENT CORPORATION
S0360X
In Commercial Distribution

  • D832S0360X0 ()
S0360X

  • Radiation shielding goggles/spectacles

Plasdent - D832S0112C0

Ultra-spec 2001, Clear Lenses
PLASDENT CORPORATION
S0112C
In Commercial Distribution

  • D832S0112C0 ()
S0112C

  • Radiation shielding goggles/spectacles

Plasdent - D832P00520

Blue Frame Gray Lens Safety Glasses, Anti-Fog & Scratch
PLASDENT CORPORATION
P005-2
In Commercial Distribution

  • D832P00520 ()
P005-2

  • Radiation shielding goggles/spectacles

Plasdent - D832P005110

Black Frame Gray Lens Safety Glasses, Anti-Fog & Scratch
PLASDENT CORPORATION
P005-11
In Commercial Distribution

  • D832P005110 ()
P005-11

  • Radiation shielding goggles/spectacles

Plasdent - D832P00320

Blue Frame Clear Lens, Anti-Fog & Scratch
PLASDENT CORPORATION
P003-2
In Commercial Distribution

  • D832P00320 ()
P003-2

  • Radiation shielding goggles/spectacles

Plasdent - D832P003110

Black Frame Clear Lens Safety Glasses, Anti-Fog & Scratch
PLASDENT CORPORATION
P003-11
In Commercial Distribution

  • D832P003110 ()
P003-11

  • Radiation shielding goggles/spectacles

Plasdent - D832P001120

Orange UV Safety Glasses, Anti-Fog & Scratch
PLASDENT CORPORATION
P001-12
In Commercial Distribution

  • D832P001120 ()
P001-12

  • Radiation shielding goggles/spectacles

Plasdent - D832P00100

Clear Safety Glasses, Anti-Fog & Scratch
PLASDENT CORPORATION
P001-0
In Commercial Distribution

  • D832P00100 ()
P001-0

  • 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
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