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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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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
Zirconia Implant One Piece Ø 4.3 x 10
Z7, LLC
Z14310
In Commercial Distribution

  • 00860010390023 ()

  • Outer Diameter: 4.3 Millimeter
  • Length: 10 Millimeter


  • Screw endosteal dental implant, one-piece
Zirconia Implant One Piece Ø 3.7 x 13
Z7, LLC
Z13713
In Commercial Distribution

  • 00860010390016 ()

  • Outer Diameter: 3.7 Millimeter
  • Length: 13 Millimeter


  • Screw endosteal dental implant, one-piece
Zirconia Implant One Piece Ø 3.7 x 10
Z7, LLC
Z13710
In Commercial Distribution

  • 00860010390009 ()

  • Outer Diameter: 3.7 Millimeter
  • Length: 10 Millimeter


  • Screw endosteal dental implant, one-piece
ECG Cable, 3 Lead, 6pin, Grabber, One Piece
Unimed Medical Supplies, Inc.
AE1006
In Commercial Distribution

  • 06936735460854 ()


  • Electrocardiographic lead set, reusable
ECG Cable 5 Lead 6pin Grabber One Piece
Unimed Medical Supplies, Inc.
AE2004
In Commercial Distribution

  • 06936735468201 ()


  • Electrocardiographic lead set, reusable
One piece EKG Diagnosis Cable for Welch Allyn
Unimed Medical Supplies, Inc.
10003
In Commercial Distribution

  • 06936735468034 ()


  • Electrocardiographic lead set, reusable
MD One® Stainless Steel Stethoscope, Gold, MDF11
MDF Instruments Medifriend Inc.
MDF777K11
In Commercial Distribution

  • 06940211620519 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, Infant, MDF08
MDF Instruments Medifriend Inc.
MDF777I08
In Commercial Distribution

  • 06940211620380 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, Infant, MDF09
MDF Instruments Medifriend Inc.
MDF777I09
In Commercial Distribution

  • 06940211620335 ()


  • Mechanical external stethoscope
MD One® Stainless Steel Stethoscope, Infant, MDF03
MDF Instruments Medifriend Inc.
MDF777I03
In Commercial Distribution

  • 06940211620311 ()


  • Mechanical external stethoscope
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