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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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Blake Kuwahara - 00810110310087

ALBERS - Midnight - 51 * 19 - 145
Fade To Grey Corp.
Albers-Midnight
In Commercial Distribution

  • G131ALBERSMD0 ()
  • 00810110310087 ()


  • Spectacle frame

Blake Kuwahara - 00810110310070

ALBERS Indigo Horn-Sun - 51 * 19 - 145 CAT 3
Fade To Grey Corp.
Albers-Indgo Hrn-Sun
In Commercial Distribution

  • G131ALBERSIH0S0 ()
  • 00810110310070 ()


  • Tinted non-prescription spectacles

Blake Kuwahara - 00810110310063

ALBERS - Indigo Horn - 51 * 19 - 145
Fade To Grey Corp.
Albers-Indgo Hrn
In Commercial Distribution

  • G131ALBERSIH0 ()
  • 00810110310063 ()


  • Spectacle frame

Blake Kuwahara - 00810110310056

ALBERS Grey Fade-Sun - 51 * 19 - 145 CAT 2
Fade To Grey Corp.
Albers-Grey Fade-Sun
In Commercial Distribution

  • G131ALBERSGF0S0 ()
  • 00810110310056 ()


  • Tinted non-prescription spectacles

Blake Kuwahara - 00810110310049

ALBERS - Grey Fade - 51 * 19 - 145
Fade To Grey Corp.
Albers-Grey Fade
In Commercial Distribution

  • G131ALBERSGF0 ()
  • 00810110310049 ()


  • Spectacle frame

Blake Kuwahara - 00810110310032

ALBERS Chestnut Fade-Sun - 51 * 19 - 145 CAT 2
Fade To Grey Corp.
Albers-Chstnt Fd-Sun
In Commercial Distribution

  • G131ALBERSCHF0S0 ()
  • 00810110310032 ()


  • Tinted non-prescription spectacles

Blake Kuwahara - 00810110310025

ALBERS - Chestnut Fade - 51 * 19 - 145
Fade To Grey Corp.
Albers-Chstnt Fd
In Commercial Distribution

  • G131ALBERSCHF0 ()
  • 00810110310025 ()


  • Spectacle frame

Blake Kuwahara - 00810110310018

ALBERS Brown Horn-Sun - 51 * 19 - 145 CAT 2
Fade To Grey Corp.
Albers-Brown Hrn-Sun
In Commercial Distribution

  • G131ALBERSBNH0S0 ()
  • 00810110310018 ()


  • Tinted non-prescription spectacles

Blake Kuwahara - 00810110310001

ALBERS - Brown Horn - 51 * 19 - 145
Fade To Grey Corp.
Albers-Brown Hrn
In Commercial Distribution

  • 00810110310001 ()
  • G131ALBERSBNH0 ()


  • Spectacle frame

EasiSlush - 00860001991208

EasiSlush (Sodium Chloride Solution for Sterile Slush Preparation) is 1.25L sterile 0.9% Sodium Chloride Solution in a 2L bag. It is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport.
Bridge To Life Ltd.
BTLE-1250
In Commercial Distribution

  • 00860001991208 ()
  • 10860001991205 ()


  • Inhalation therapy saline solution, isotonic

Summit to Sea - 00866115000324

No Description
SUMMIT TO SEA, LLC
The Grand Dive Hyperbaric Chamber
In Commercial Distribution

  • 00866115000324 ()


  • Hyperbaric chamber, portable

Summit to Sea - 00866115000317

No Description
SUMMIT TO SEA, LLC
The Shallow Dive Hyperbaric Chamber
In Commercial Distribution

  • 00866115000317 ()


  • Hyperbaric chamber, portable

Summit to Sea - 00866115000300

No Description
SUMMIT TO SEA, LLC
The Dive Hyperbaric Chamber
In Commercial Distribution

  • 00866115000300 ()


  • Hyperbaric chamber, portable

CALCANEA™ - 10381780044802

The depth gauge is used to evaluate the appropriate screw length to implant.
NEWDEAL
129134ND
Not in Commercial Distribution

  • M248129134ND1 ()
  • 10381780044802 ()


  • Surgical depth gauge, reusable

Fixone Instrument - 08800039102186

Instrument used to guide the implant or another instrument to the surgical site.
AJU PHARM. CO., LTD.
Fixone.I.F-G
In Commercial Distribution

  • 08800039102186 ()


  • Arthroscopic obturator

3D TPR - 05060608880928

Accessory to the 1230 3D SCANNER used to measure the Tissue Phantom Ratio.
SUN NUCLEAR CORP.
1230000-4Z
In Commercial Distribution

1230000-4Z

  • Accelerator system quality assurance device

3D TPR - 05060608880300

Accessory to the 1230 3D SCANNER used to measure the Tissue Phantom Ratio
SUN NUCLEAR CORP.
1230680Z
Not in Commercial Distribution

1230000-4Z

  • Accelerator system quality assurance device

ML7 Eye Marker - 00850724001902

Eye Marker use to mark the cornea to orientate the ML7 Vacuum Ring
MED LOGICS INC
2100ML7
In Commercial Distribution

  • 00850724001902 ()
2100ML7

  • Eyeball fixation instrument, reusable

Terumo® Advanced Perfusion System 1 - 00886799000830

Cable used to connect the CDI data module to the intended CDI device.
Terumo Cardiovascular Systems Corporation
804981
In Commercial Distribution

  • 00886799000830 ()
804981

  • Cardiopulmonary bypass system mounting unit

MM MARKED PAPER POINTS - 08806383576062

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT ASST(F1,F2,F3,F4,F5)
In Commercial Distribution

  • 08806383576062 ()
MP250-693

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383576055

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT ASST(F4,F5)
In Commercial Distribution

  • 08806383576055 ()
MP250-692

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383576048

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT ASST(F1,F2,F3)
In Commercial Distribution

  • 08806383576048 ()
MP250-691

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383576031

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT F5
In Commercial Distribution

  • 08806383576031 ()
MP250-605

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383576024

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT F4
In Commercial Distribution

  • 08806383576024 ()
MP250-604

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383576017

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT F3
In Commercial Distribution

  • 08806383576017 ()
MP250-603

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383576000

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT F2
In Commercial Distribution

  • 08806383576000 ()
MP250-602

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383575997

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT ASST(F1,F2,F3,F4,F5)
In Commercial Distribution

  • 08806383575997 ()
CMP250-S693

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383575980

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT ASST(F4,F5)
In Commercial Distribution

  • 08806383575980 ()
CMP250-S692

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383575973

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT ASST(F1,F2,F3)
In Commercial Distribution

  • 08806383575973 ()
CMP250-S691

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383575966

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT F5
In Commercial Distribution

  • 08806383575966 ()
CMP250-S605

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383575959

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT F4
In Commercial Distribution

  • 08806383575959 ()
CMP250-S604

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383575942

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT F3
In Commercial Distribution

  • 08806383575942 ()
CMP250-S603

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383575935

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT F2
In Commercial Distribution

  • 08806383575935 ()
CMP250-S602

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383575928

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT F1
In Commercial Distribution

  • 08806383575928 ()
CMP250-S601

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383571364

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT NEXT ASST(X2/X3)
In Commercial Distribution

  • 08806383571364 ()
MP267-692

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383571357

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT NEXT ASST(X2/X5)
In Commercial Distribution

  • 08806383571357 ()
MP267-691

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383571340

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT NEXT X5
In Commercial Distribution

  • 08806383571340 ()
MP267-605

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383571333

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT NEXT X4
In Commercial Distribution

  • 08806383571333 ()
MP267-604

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383571326

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT NEXT X3
In Commercial Distribution

  • 08806383571326 ()
MP267-603

  • Endodontic paper point

MM MARKED PAPER POINTS - 08806383571319

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PROT NEXT X2
In Commercial Distribution

  • 08806383571319 ()
MP267-602

  • Endodontic paper point
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