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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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, 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, 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, Small
TRONEX INTERNATIONAL, INC.
9770-10
In Commercial Distribution

  • 00097604977012 ()
  • 10097604977019 ()


  • 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
INFANT W/MANOMETER,12" CORRUGATED RESERVOIR,M1 MASK & NEW STYLE O2 RESERV
VENTLAB, LLC
VN3106MC-M1V
In Commercial Distribution

  • 20889483097998 ()
  • 10889483097991 ()

  • Total Volume: 300 Milliliter


  • Pulmonary resuscitator, manual, single-use
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
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
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
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
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
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
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
New Style Thyroid Collar 621US Small - 24" L - 0.5mm Reg Lead (RL)
Shielding International Inc.
621USRL
In Commercial Distribution

  • G031621USRL0 ()


  • Radiation shielding collar
New Style Thyroid Collar 611NS Small - 22.5" L - 0.5mm Reg Lead (RL)
Shielding International Inc.
611NSSRL
In Commercial Distribution

  • G031611NSSRL0 ()


  • Radiation shielding collar
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
Image-Line, micro blade, short teeth, 14x50mm, Blue Titanium Blade, New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6149TH
In Commercial Distribution

  • 00888515299719 ()
73-6149TH

  • Surgical retractor/retraction system blade, reusable
Image-Line, micro blade, short teeth, 14x45mm, Blue Titanium Blade, New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6148TH
In Commercial Distribution

  • 00888515299702 ()
73-6148TH

  • Surgical retractor/retraction system blade, reusable
Image-Line, micro blade, short teeth, 14x40mm, Blue Titanium Blade, New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6147TH
In Commercial Distribution

  • 00888515299696 ()
73-6147TH

  • Surgical retractor/retraction system blade, reusable
Image-Line, micro blade, short teeth, 14x35mm, Blue Titanium Blade, New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6146TH
In Commercial Distribution

  • 00888515299689 ()
73-6146TH

  • Surgical retractor/retraction system blade, reusable
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
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
Klarity Customized Head Mold 15x31cm with New Neck Flare and 6cm bump
Klarity Medical Products, LLC
R550-PS45
In Commercial Distribution

  • 00817355027961 ()


  • Patient positioning foam mould kit
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
DENTAL IMPLANT ABUTMENT NEW Plastic Abutment for 3D with collar LAB Impression
Ritter Implants GmbH & Co. KG
3DSPA-8C
In Commercial Distribution

  • ERIT3DSPA8C1 ()


  • Screw endosteal dental implant, two-piece
Reusable SpO2 Sensor/CSI/Ear clip/Adult/3.0M/New DB9M Right Angle
Unimed Medical Supplies, Inc.
U910-75N
In Commercial Distribution

  • 06945664825405 ()


  • Pulse oximeter probe, reusable
Reusable SpO2 Sensor/CSI/Finger Clip/Adult/3.0M/New DB9M Right Angle
Unimed Medical Supplies, Inc.
U410-75N
In Commercial Distribution

  • 06945664825153 ()


  • Pulse oximeter probe, reusable
Reusable SpO2 Sensor/CSI/Soft Tip/Adult/3.0M/New DB9M Right Angle
Unimed Medical Supplies, Inc.
U410S-75N
In Commercial Distribution

  • 06945664822763 ()


  • Pulse oximeter probe, reusable
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