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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iNAP One sleep therapy system whole set package
SOMNICS, INC.
91000-07
In Commercial Distribution

  • 04719878320009 ()
91000-07

  • Intraoral negative-pressure sleep apnoea unit
Three In One Respiratory Care System- Inspiratory Filter
FISHER & PAYKEL HEALTHCARE LIMITED
RT016
In Commercial Distribution

  • 09420012429377 ()
  • 09420012432339 ()
RT016

  • Microbial medical gas filter, single-use
ColpoWave Balloon blister pack containing one sterile unit
SURGITOOLS PTY. LTD.
CBD
In Commercial Distribution

  • 09351599000119 ()


  • Colpotomy tube
CREO ONE Ø7.5 x 55mm Robotic, Modular Screw
GLOBUS MEDICAL, INC.
1134.1755
In Commercial Distribution

  • 00193982299989 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE Ø7.5 x 50mm Robotic, Modular Screw
GLOBUS MEDICAL, INC.
1134.1750
In Commercial Distribution

  • 00193982299972 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE Ø7.5 x 45mm Robotic, Modular Screw
GLOBUS MEDICAL, INC.
1134.1745
In Commercial Distribution

  • 00193982299965 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE Ø7.5 x 40mm Robotic, Modular Screw
GLOBUS MEDICAL, INC.
1134.1740
In Commercial Distribution

  • 00193982299958 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE Ø7.5 x 35mm Robotic, Modular Screw
GLOBUS MEDICAL, INC.
1134.1735
In Commercial Distribution

  • 00193982299941 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE Ø6.5 x 55mm Robotic, Modular Screw
GLOBUS MEDICAL, INC.
1134.1655
In Commercial Distribution

  • 00193982299798 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE Ø6.5 x 50mm Robotic, Modular Screw
GLOBUS MEDICAL, INC.
1134.1650
In Commercial Distribution

  • 00193982299781 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE Ø6.5 x 45mm Robotic, Modular Screw
GLOBUS MEDICAL, INC.
1134.1645
In Commercial Distribution

  • 00193982299774 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE Ø6.5 x 40mm Robotic, Modular Screw
GLOBUS MEDICAL, INC.
1134.1640
In Commercial Distribution

  • 00193982299767 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE Ø6.5 x 35mm Robotic, Modular Screw
GLOBUS MEDICAL, INC.
1134.1635
In Commercial Distribution

  • 00193982299750 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE Ø5.5 x 50mm Robotic, Modular Screw
GLOBUS MEDICAL, INC.
1134.1550
In Commercial Distribution

  • 00193982299590 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE Ø5.5 x 45mm Robotic, Modular Screw
GLOBUS MEDICAL, INC.
1134.1545
In Commercial Distribution

  • 00193982299583 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE Ø5.5 x 40mm Robotic, Modular Screw
GLOBUS MEDICAL, INC.
1134.1540
In Commercial Distribution

  • 00193982299576 ()


  • Trans-facet-screw internal spinal fixation system, sterile
CREO ONE Ø5.5 x 35mm Robotic, Modular Screw
GLOBUS MEDICAL, INC.
1134.1535
In Commercial Distribution

  • 00193982299569 ()


  • Trans-facet-screw internal spinal fixation system, sterile
Operating Scissors Sharp Blunt Straight One Blade Serrated
SONTEC INSTRUMENTS, INC.
110-225
In Commercial Distribution

  • 00192896103634 ()

  • Length: 5.5 Inch


  • General-purpose surgical scissors, reusable
Ingrown Nail Splitting Scissor Straight One Serrated Blade
SONTEC INSTRUMENTS, INC.
1103-613
In Commercial Distribution

  • 00192896102408 ()

  • Length: 6 Inch


  • Nail splitting scissors
LISTER BANDAGE SCISSORS ONE LARGE FINGER RING QUANTUM
SONTEC INSTRUMENTS, INC.
110-351Q
In Commercial Distribution

  • 00192896097339 ()

  • Length: 8 Inch
110-351Q

  • Bandage scissors, reusable
REDUCTION FORCEPS WITH POINTS ONE BENT TIP/200MM
Synthes GmbH
SD399.941
In Commercial Distribution

  • H679SD3999410 ()
  • 10886982007131 ()
SD399941

  • Bone holding forceps
REDUCTION FORCEPS WITH POINTS ONE BENT TIP/174MM
Synthes GmbH
SD399.940
In Commercial Distribution

  • H679SD3999400 ()
  • 10886982007124 ()
SD399940

  • Bone holding forceps
One pair bite blocks, small, silicone, Latex Free
A. TITAN INSTRUMENTS, INC.
Small
In Commercial Distribution

  • 00841685103583 ()


  • Dental impression tray, single-use
ANNULOTOME Ø 2.5MM WL 350MM one ended, reusable
Richard Wolf GmbH
8792581
In Commercial Distribution

  • 04055207043226 ()

  • Length: 350 Millimeter
  • Outer Diameter: 2.5 Millimeter
8792.581

  • Scalpel, reusable
Parametrium scissors TC 30,5cm, angled, one serrated blade
RZ-Medizintechnik GmbH
120-538-004
In Commercial Distribution

  • 04049197036269 ()
120-538-004

  • Gynaecological scissors, reusable
Reusable non-sterile Toshiba Aquilion One CT cradle top
MEDTEC, INC.
MTIL6561
Not in Commercial Distribution

  • 00841439106211 ()

  • Length: 98.5 Inch
  • Width: 22.6 Inch
MTIL6561

  • Indexed-immobilization patient positioning system
Reusable non-sterile Toshiba Aquilion One CT cradle top
MEDTEC, INC.
MTIL6501
Not in Commercial Distribution

  • 00841439106136 ()
MTIL6501

  • Indexed-immobilization patient positioning system
Siemens Biograph PET/CT one piece cradle top
MEDTEC, INC.
MTIL6022
In Commercial Distribution

  • 00841439105306 ()
MTIL6022

  • Indexed-immobilization patient positioning system
Siemens ZXT one piece couchtop with Lok-Bar™
MEDTEC, INC.
MTIL6021
Not in Commercial Distribution

  • 00841439105290 ()
MTIL6021

  • Indexed-immobilization patient positioning system
GE VCT Global 1700 one piece cradle top
MEDTEC, INC.
MTIL6322
In Commercial Distribution

  • 00841439105887 ()
MTIL6322

  • Indexed-immobilization patient positioning system
Balfour lateral blades, one pair 64mm deep fenestrated
RZ-Medizintechnik GmbH
170-865-008
In Commercial Distribution

  • 04049197536516 ()
170-865-008

  • Self-retaining surgical retractor, reusable
Balfour lateral blades, one pair 100mm deep closed
RZ-Medizintechnik GmbH
170-865-013
In Commercial Distribution

  • 04049197536561 ()
170-865-013

  • Self-retaining surgical retractor, reusable
Balfour lateral blades, one pair 89mm deep closed
RZ-Medizintechnik GmbH
170-865-012
In Commercial Distribution

  • 04049197536554 ()
170-865-012

  • Self-retaining surgical retractor, reusable
Balfour lateral blades, one pair 64mm deep closed
RZ-Medizintechnik GmbH
170-865-011
In Commercial Distribution

  • 04049197536547 ()
170-865-011

  • Self-retaining surgical retractor, reusable
Balfour lateral blades, one pair 100mm deep fenestrated
RZ-Medizintechnik GmbH
170-865-010
In Commercial Distribution

  • 04049197536530 ()
170-865-010

  • Self-retaining surgical retractor, reusable
Balfour lateral blades, one pair 89mm deep fenestrated
RZ-Medizintechnik GmbH
170-865-009
In Commercial Distribution

  • 04049197536523 ()
170-865-009

  • Self-retaining surgical retractor, reusable
REMstar Auto A-Flex System One 60 Series, Argentina
Respironics, Inc.
REMstar Auto A-Flex, 60 Series, AR
In Commercial Distribution

  • 00606959048300 ()
AR561S

  • Home CPAP unit
REMstar Pro C-Flex+, System One 60 Series, Argentina
Respironics, Inc.
REMstar Pro C-Flex+, 60 Series, AR
In Commercial Distribution

  • 00606959048294 ()
AR461S

  • Home CPAP unit
BiPAP autoSV Advanced System One 60 Series, Italy
Respironics, Inc.
BiPAP autoSV Advanced 60 Series, IT
In Commercial Distribution

  • 00606959048263 ()
IT961S

  • Portable electric ventilator
BiPAP Auto BiFlex, System One 60 Series, italy
Respironics, Inc.
BiPAP Auto BiFlex, System One 60 Series, Italy
In Commercial Distribution

  • 00606959048256 ()
IT761S

  • Home BPAP unit
REMstar Auto A-Flex System One 60 Series, Italy
Respironics, Inc.
REMstar Auto A-Flex System One 60 Series, Italy
Not in Commercial Distribution

  • 00606959048225 ()
IT561S

  • Home CPAP unit
REMstar Pro C-Flex+, System One 60 Series, Italy
Respironics, Inc.
REMstar Pro C-Flex+, System One 60 Series, Italy
Not in Commercial Distribution

  • 00606959048218 ()
IT461S

  • Home CPAP unit
Saliva Ejector Traps, One Size Fits All, Clear
PLASDENT CORPORATION
8100
In Commercial Distribution

  • D83281000 ()
  • D83281001 ()
8100

  • Dental suction system in-line filter
Teeth Bleaching Trays, One Size, Boil & Bite Moldable
PLASDENT CORPORATION
MG004
In Commercial Distribution

  • D832MG0040 ()
  • D832MG0041 ()
MG004

  • Teeth whitening tray
One person use unuversal(L) air pad 1ea
DAESUNG MAREF CO.,LTD.
CTCULDA
Not in Commercial Distribution

  • 18809315679692 ()
  • 08809315679695 ()
  • 28809315679699 ()
  • 38809315679696 ()


  • Circulating-fluid localized thermal therapy system pack, reusable
One person use universal(M) air pad 1ea
DAESUNG MAREF CO.,LTD.
CTCUMDA
Not in Commercial Distribution

  • 18809315679678 ()
  • 08809315679671 ()
  • 28809315679675 ()
  • 38809315679672 ()


  • Circulating-fluid localized thermal therapy system pack, reusable
6 chamber FULL BODY EXTENSION ZIPPER (One size)
DAESUNG MAREF CO.,LTD.
AC0634
Not in Commercial Distribution

  • 28809315679132 ()
  • 08809315679138 ()
  • 18809315679135 ()
  • 08809315679121 ()


  • Pneumatic massager
  • Multi-chamber venous compression system garment, reusable
OPTIGLAZE™ OPTIGLAZE Contains: One (15 mL) bottle.
Gc America Inc.
002613
In Commercial Distribution

  • D0470026131 ()

  • Total Volume: 15 Milliliter
002613

  • Dental unfilled resin sealant/coating
Unisoft ONE Single Patient Use Alternating Pressure Mattress
Unisoft Medical Corporation
UO-SPUM-800
In Commercial Distribution

  • 00863220000416 ()
UO-SPUM-800

  • Alternating-pressure bed mattress
Zirconia Implant One Piece Ø 4.3 x 13
Z7, LLC
Z14313
In Commercial Distribution

  • 00860010390030 ()

  • Outer Diameter: 4.3 Millimeter
  • Length: 13 Millimeter


  • Screw endosteal dental implant, one-piece
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