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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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M800X-M/ST, STAR Backend, Quattro Spray, Instant Stop, 25 MTHS WTY (NEW)
Beyes Dental Canada Inc
HP3054X
In Commercial Distribution

  • 00628504370285 ()


  • Dental power tool system handpiece, pneumatic
M800X-M/N, NSK Backend, Quattro Spray, Instant Stop, 25 MTHS WTY (NEW)
Beyes Dental Canada Inc
HP3043X
In Commercial Distribution

  • 00628504370247 ()


  • Dental power tool system handpiece, pneumatic
M800X-M/K, KaVo Backend, Quattro Spray, Instant Stop, 25 MTHS WTY (NEW)
Beyes Dental Canada Inc
HP3036X
In Commercial Distribution

  • 00628504370216 ()


  • Dental power tool system handpiece, pneumatic
New Orleans needle holder, 7'', straight, serrated TC jaws, gold ring handle
AMBLER SURGICAL CORP.
New Orleans needle holder
In Commercial Distribution

  • 00190660119843 ()
53-115

  • Suturing needle holder, reusable
ENNOVATE, S4 SPINAL SYSTEM Compression Forceps, new version, stainless steel, non-sterile, reusable
Aesculap AG
FW210R
In Commercial Distribution

  • 04038653393596 ()
FW210R

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Blue, Extra-Large
TRONEX INTERNATIONAL, INC.
9770-35
In Commercial Distribution

  • 00097604977043 ()
  • 10097604977040 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Blue, Medium
TRONEX INTERNATIONAL, INC.
9770-20
In Commercial Distribution

  • 00097604977029 ()
  • 10097604977026 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Blue, Extra-Small
TRONEX INTERNATIONAL, INC.
9770-05
In Commercial Distribution

  • 00097604977005 ()
  • 10097604977002 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Blue, 2X-Large
TRONEX INTERNATIONAL, INC.
9770-40
In Commercial Distribution

  • 00097604977050 ()
  • 10097604977057 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Blue, Large
TRONEX INTERNATIONAL, INC.
9770-30
In Commercial Distribution

  • 00097604977036 ()
  • 10097604977033 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Glove, Exam, Nitrile, NEW AGE, Chemotherapy Rated, Fingertip-Textured, Powder-Free, Latex-Free, Violet-Blue, Small
TRONEX INTERNATIONAL, INC.
9770-10
In Commercial Distribution

  • 00097604977012 ()
  • 10097604977019 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
POWER IMPLANT GUIDE NEW EXTENTION KIT WITH MEASUREMENTS PARALLELING GUIDE WITH BOX
Power Dental U.S.A. Inc.
1979N2
In Commercial Distribution

  • D9431979N2 ()
1979N2

  • Dressing/utility forceps, scissors-like, reusable
  • General-purpose calliper, metallic
POWER IMPLANT GUIDE NEW EXTENTION KIT WITH MEASUREMENTS PARALLELING GUIDE WITH BOX
Power Dental U.S.A. Inc.
N1979N2
In Commercial Distribution

  • D943N1979N2 ()
N1979N2

  • General-purpose calliper, metallic
PAUL BANDITT BECK 87 ELEVATOR, 4.0MM , SERRATED, STANDARD HANDLE, New Thinner tip
Terlain Enterprises, Inc.
ELEB87
In Commercial Distribution

  • D955ELEB871 ()


  • Dental elevator, tooth/root
PAUL BANDITT BECK 86 ELEVATOR, 3.5MM , SERRATED, STANDARD HANDLE, New Thinner Tip
Terlain Enterprises, Inc.
ELEB86
In Commercial Distribution

  • D955ELEB861 ()


  • Dental elevator, tooth/root
IQ HOLTER PLUG-IN SOFTWARE v10.0.6: New Software Release for Midmark Digital Holter.
MIDMARK CORPORATION
P/N 4-100-3140
In Commercial Distribution

  • 00841709118067 ()


  • Electrocardiographic long-term ambulatory recording analyser
LECRON Carver Dental Wax Amalgam Spatula Stainless Steel Lab Pro New Instruments
Wise Linkers, LLC
242557
In Commercial Distribution

  • D1272425571 ()
1

  • Dental restoration carver, amalgam, reusable
Silicone Gel Sheet. Treatment for red and raised, old and new scars
SMITH & NEPHEW MEDICAL LIMITED
66250704
In Commercial Distribution

  • 05000223441784 ()
  • 05000223441586 ()
  • 05000223441791 ()
  • 05000223441807 ()
66250704 & 66250705

  • Scar-management dressing, reusable
Silicone Gel Sheet. Treatment for red and raised, old and new scars
SMITH & NEPHEW MEDICAL LIMITED
66250706, 66250707
In Commercial Distribution

  • 05000223441814 ()
  • 05000223441579 ()
  • 05000223441821 ()
  • 05000223441654 ()
  • 05000223498351 ()
66250706, 66250707

  • Scar-management dressing, reusable
OMX52P Split Horizontal Corded Foam Grounding Plate- New Oversized Gel -Single Pack
MEDIMAX TECH INC.
OMX52P ESU Plate
In Commercial Distribution

  • 20817325022907 ()
  • 10817325022900 ()
  • 00817325022903 ()


  • Electrosurgical return electrode, single-use
Image-Line Notched Medial Rtrc Blade, 23 x 65mm, navy New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6167H
In Commercial Distribution

  • 00888515190849 ()
73-6167H

  • Surgical retractor/retraction system blade, reusable
Image-Line Notched Medial Rtrc Blade, 23 x 60mm, gold New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6166H
In Commercial Distribution

  • 00888515190825 ()
73-6166H

  • Surgical retractor/retraction system blade, reusable
Image-Line Notched Medial Rtrc Blade, 23 x 55mm, black New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6165H
In Commercial Distribution

  • 00888515190801 ()
73-6165H

  • Surgical retractor/retraction system blade, reusable
Image-Line Notched Medial Rtrc Blade, 23 x 50mm, violet New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6164H
In Commercial Distribution

  • 00888515190788 ()
73-6164H

  • Surgical retractor/retraction system blade, reusable
Image-Line Notched Medial Rtrc Blade, 23 x 45mm, green New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6163H
In Commercial Distribution

  • 00888515190764 ()
73-6163H

  • Surgical retractor/retraction system blade, reusable
Image-Line Notched Medial Rtrc Blade, 23 x 40mm, red New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6162H
In Commercial Distribution

  • 00888515190740 ()
73-6162H

  • Surgical retractor/retraction system blade, reusable
Image-Line Notched Medial Rtrc Blade, 23 x 35mm, blue New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6161H
In Commercial Distribution

  • 00888515190726 ()
73-6161H

  • Surgical retractor/retraction system blade, reusable
Image-Line Notched Medial Retr Blade, 23 x 30mm, silver New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6160H
In Commercial Distribution

  • 00888515190702 ()
73-6160H

  • Surgical retractor/retraction system blade, reusable
Image-Line, micro blade, short teeth, 14x60mm, Blue Titanium Blade, New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6151TH
In Commercial Distribution

  • 00888515299733 ()
73-6151TH

  • Surgical retractor/retraction system blade, reusable
Image-Line, micro blade, short teeth, 14x55mm, Blue Titanium Blade, New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6150TH
In Commercial Distribution

  • 00888515299726 ()
73-6150TH

  • Surgical retractor/retraction system blade, reusable
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