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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BK1014 - Brushed Midnight - 52 * 22 - 145
Fade To Grey Corp.
BK1014-Brsh Mdnt
In Commercial Distribution

  • G131BK1014BMD0 ()
  • 00810110311046 ()


  • Spectacle frame
BK1013 Gold-Sun - 47 * 21 - 145 CAT 2
Fade To Grey Corp.
BK1013-Gold-Sun
In Commercial Distribution

  • G131BK1013GL0S0 ()
  • 00810110311039 ()


  • Tinted non-prescription spectacles
BK1013 - Gold - 47 * 21 - 145
Fade To Grey Corp.
BK1013-Gold
In Commercial Distribution

  • G131BK1013GL0 ()
  • 00810110311022 ()


  • Spectacle frame
BK1013 Black-Sun - 47 * 21 - 145 CAT 3
Fade To Grey Corp.
BK1013-Black-Sun
In Commercial Distribution

  • G131BK1013BL0S0 ()
  • 00810110311015 ()


  • Tinted non-prescription spectacles
BK1013 - Black - 47 * 21 - 145
Fade To Grey Corp.
BK1013-Black
In Commercial Distribution

  • G131BK1013BL0 ()
  • 00810110311008 ()


  • Spectacle frame
BK1013 Antique Pewter-Sun - 47 * 21 - 145 CAT 3
Fade To Grey Corp.
BK1013-Ant Pewtr-Sun
In Commercial Distribution

  • G131BK1013AP0S0 ()
  • 00810110310995 ()


  • Tinted non-prescription spectacles
BK1013 - Antique Pewter - 47 * 21 - 145
Fade To Grey Corp.
BK1013-Ant Pewtr
In Commercial Distribution

  • G131BK1013AP0 ()
  • 00810110310988 ()


  • Spectacle frame
BK1013 Antique Brown-Sun - 47 * 21 - 145 CAT 2
Fade To Grey Corp.
BK1013-Ant Brown-Sun
In Commercial Distribution

  • G131BK1013AB0S0 ()
  • 00810110310971 ()


  • Tinted non-prescription spectacles
BK1013 - Antique Brown - 47 * 21 - 145
Fade To Grey Corp.
BK1013-Ant Brown
In Commercial Distribution

  • G131BK1013AB0 ()
  • 00810110310964 ()


  • Spectacle frame
BK1012 - Snake - 50 * 19 - 145
Fade To Grey Corp.
BK1012-Snake
In Commercial Distribution

  • G131BK1012SN0 ()
  • 00810110310940 ()


  • Spectacle frame
BK1012 Mauve-Sun - 50 * 19 - 145 CAT 2
Fade To Grey Corp.
BK1012-Mauve-Sun
In Commercial Distribution

  • G131BK1012MV0S0 ()
  • 00810110310919 ()


  • Tinted non-prescription spectacles
BK1012 - Mauve - 50 * 19 - 145
Fade To Grey Corp.
BK1012-Mauve
In Commercial Distribution

  • G131BK1012MV0 ()
  • 00810110310902 ()


  • Spectacle frame
BK1012 Brown Straw-Sun - 50 * 19 - 145 CAT 2
Fade To Grey Corp.
BK1012-Brwn Strw-Sun
In Commercial Distribution

  • G131BK1012BNS0S0 ()
  • 00810110310896 ()


  • Tinted non-prescription spectacles
BK1012 - Brown Straw - 50 * 19 - 145
Fade To Grey Corp.
BK1012-Brwn Strw
In Commercial Distribution

  • G131BK1012BNS0 ()
  • 00810110310889 ()


  • Spectacle frame
BK1011 Sage-Sun - 49 * 20 - 145 CAT 3
Fade To Grey Corp.
BK1011-Sage-Sun
In Commercial Distribution

  • G131BK1011SG0S0 ()
  • 00810110310872 ()


  • Tinted non-prescription spectacles
BK1011 - Sage - 49 * 20 - 145
Fade To Grey Corp.
BK1011-Sage
In Commercial Distribution

  • G131BK1011SG0 ()
  • 00810110310865 ()


  • Spectacle frame
BK1011 Rhino-Sun - 49 * 20 - 145 CAT 2
Fade To Grey Corp.
BK1011-Rhino-Sun
In Commercial Distribution

  • G131BK1011RH0S0 ()
  • 00810110310858 ()


  • Tinted non-prescription spectacles
BK1011 - Mocha - 49 * 20 - 145
Fade To Grey Corp.
BK1011-Mocha
In Commercial Distribution

  • G131BK1011MOC0 ()
  • 00810110310803 ()


  • Spectacle frame
BK1010 - Burgundy - 49 * 20 - 145
Fade To Grey Corp.
BK1010-Burgundy
In Commercial Distribution

  • G131BK1010BG0 ()
  • 00810110310728 ()


  • Spectacle frame
BK1009 Flint-Sun - 50 * 19 - 145 CAT 2
Fade To Grey Corp.
BK1009-Flint-Sun
In Commercial Distribution

  • G131BK1009FLT0S0 ()
  • 00810110310711 ()


  • Tinted non-prescription spectacles
BK1009 - Flint - 50 * 19 - 145
Fade To Grey Corp.
BK1009-Flint
In Commercial Distribution

  • G131BK1009FLT0 ()
  • 00810110310704 ()


  • Spectacle frame
BK1009 Brown Horn-Sun - 50 * 19 - 145 CAT 2
Fade To Grey Corp.
BK1009-Brown Hrn-Sun
In Commercial Distribution

  • G131BK1009BNH0S0 ()
  • 00810110310698 ()


  • Tinted non-prescription spectacles
BK1008 Navy Horn-Sun - 52 * 19 - 145 CAT 3
Fade To Grey Corp.
BK1008-Navy Horn-Sun
In Commercial Distribution

  • G131BK1008NVH0S0 ()
  • 00810110310636 ()


  • Tinted non-prescription spectacles
BK1008 - Navy Horn - 52 * 19 - 145
Fade To Grey Corp.
BK1008-Navy Horn
In Commercial Distribution

  • G131BK1008NVH0 ()
  • 00810110310629 ()


  • Spectacle frame
BK1008 Brown Horn-Sun - 52 * 19 - 145 CAT 2
Fade To Grey Corp.
BK1008-Brown Hrn-Sun
In Commercial Distribution

  • G131BK1008BNH0S0 ()
  • 00810110310612 ()


  • Tinted non-prescription spectacles
BK1008 - Brown Horn - 52 * 19 - 145
Fade To Grey Corp.
BK1008-Brown Hrn
In Commercial Distribution

  • G131BK1008BNH0 ()
  • 00810110310605 ()


  • Spectacle frame
BK1008 Black Horn-Sun - 52 * 19 - 145 CAT 3
Fade To Grey Corp.
BK1008-Black Hrn-Sun
In Commercial Distribution

  • G131BK1008BH0S0 ()
  • 00810110310599 ()


  • Tinted non-prescription spectacles
BK1008 - Black Horn - 52 * 19 - 145
Fade To Grey Corp.
BK1008-Black Hrn
In Commercial Distribution

  • G131BK1008BH0 ()
  • 00810110310582 ()


  • Spectacle frame
BK1007 Smoke-Sun - 50 * 17 - 145 CAT 2
Fade To Grey Corp.
BK1007-Smoke-Sun
In Commercial Distribution

  • G131BK1007SM0S0 ()
  • 00810110310575 ()


  • Tinted non-prescription spectacles
BK1007 Russet-Sun - 50 * 17 - 145 CAT 2
Fade To Grey Corp.
BK1007-Russet-Sun
In Commercial Distribution

  • G131BK1007RU0S0 ()
  • 00810110310551 ()


  • Tinted non-prescription spectacles
BK1007 Olive-Sun - 50 * 17 - 145 CAT 2
Fade To Grey Corp.
BK1007-Olive-Sun
In Commercial Distribution

  • G131BK1007OV0S0 ()
  • 00810110310537 ()


  • Tinted non-prescription spectacles
BK1005 Tortoise-Sun - 52 * 20 - 145 CAT 2
Fade To Grey Corp.
BK1005-Tortoise-Sun
In Commercial Distribution

  • G131BK1005TR0S0 ()
  • 00810110310391 ()


  • Tinted non-prescription spectacles
The plate bender (6.5 threaded hole) is used to shape the plate according to the bone configuration.
NEWDEAL
219765ND
In Commercial Distribution

  • M248219765ND1 ()
  • 10381780052005 ()


  • Manual orthopaedic bender, reusable
The plate bender (3.5 threaded hole) is used to shape the plate according to the bone configuration.
NEWDEAL
219735ND
In Commercial Distribution

  • M248219735ND1 ()
  • 10381780051992 ()


  • Manual orthopaedic bender, reusable
Radiofrequency devices. Accessory intended to transmit the electric current generated by the RF generator to the tips.
INDIBA SA.
ACC1018USA
In Commercial Distribution

  • 08434251002667 ()
REVERSO applicator handle

  • Intradermal radio-frequency ablation system
The Non-Contact Tonometer is intended to be used to measure the intraocular pressure of the human eye.
Huvitz Co., Ltd.
HNT-7000
In Commercial Distribution

  • 08800019600176 ()
HNT-7000

  • Ophthalmic tonometer, battery-operated
The Auto Ref/Keratometer is intended to be used to measure the refractive power of the eye
Huvitz Co., Ltd.
HRK-8000A
In Commercial Distribution

  • 08800019600152 ()
HRK-8000A

  • Ophthalmic refractometer, manual
The Non-Contact Tonometer is intended to be used to measure the intraocular pressure of the human eye.
Huvitz Co., Ltd.
HNT-1
In Commercial Distribution

  • 08800019600428 ()
HNT-1

  • Ophthalmic tonometer, battery-operated
The Auto Ref/Keratometer is intended to be used to measure the refractive power of the eye
Huvitz Co., Ltd.
HRK-9000A
In Commercial Distribution

  • 08800019600169 ()
HRK-9000A

  • Ophthalmic refractometer, manual
The Auto Ref/Keratometer is intended to be used to measure the refractive power of the eye
Huvitz Co., Ltd.
HRK-7000A
In Commercial Distribution

  • 08800019600145 ()
HRK-7000A

  • Ophthalmic refractometer, manual
The Mitt is intended to be used to limit the movement of the patient's hands and fingers.
Kenad SG Medical, Inc.
Patient Protective Mitt with Stays Infant
In Commercial Distribution

  • M1435011201 ()
50-1120

  • Limb/torso/head restraint, single-use
The Mitt is intended to be used to limit the movement of the patient's hands and fingers.
Kenad SG Medical, Inc.
Protective Mitt with Stay Child
In Commercial Distribution

  • M1435011101 ()
50-1110

  • Limb/torso/head restraint, single-use
The Mitt is intended to be used to limit the movement of the patient's hands and fingers.
Kenad SG Medical, Inc.
Patient Protective Mitt Infant w/o Stays
In Commercial Distribution

  • M1435010201 ()
50-1020

  • Limb/torso/head restraint, single-use
The Mitt is intended to be used to limit the movement of the patient's hands and fingers.
Kenad SG Medical, Inc.
Patient Protective Mitt Child w/o Stays
In Commercial Distribution

  • M1435010101 ()
50-1010

  • Limb/torso/head restraint, single-use
The FRAXION™ Frontpiece is attached to the FRAXION™ Frame in order to set-up the patient with the mouthpiece.
3C-Medical Intelligence GmbH
P10106-101
In Commercial Distribution

  • 04056719001360 ()
P10106-101

  • Stereotactic radiosurgical/radiotherapy arch head frame
The T2Candida components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.
T2 BIOSYSTEMS, INC.
90-01794
Not in Commercial Distribution

  • M70890017940 ()


  • Multiple Candida species nucleic acid IVD, reagent
"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-PROISO-.06 PLUS 25
In Commercial Distribution

  • 08806383567442 ()
MP259-805

  • Endodontic paper point
"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
ISO 90
In Commercial Distribution

  • 08806383567336 ()
MP201-815

  • Endodontic paper point
"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
ISO 70
In Commercial Distribution

  • 08806383567312 ()
MP201-813

  • Endodontic paper point
"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
ISO 60
In Commercial Distribution

  • 08806383567305 ()
MP201-812

  • Endodontic paper point
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