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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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AuraLay XF Pit and Fissure Sealant - D820ALAYXFOW0

Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Opaque White
In Commercial Distribution

  • D820ALAYXFOW0 ()
  • D820ALAYXFOW3 ()
  • D820ALAYXFOW2 ()
  • D820ALAYXFOW1 ()
ALAYXFOW

  • Dental pit/fissure sealant

AuraLay XF Pit and Fissure Sealant - D820ALAYXFNT0

Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Natural Translucent
In Commercial Distribution

  • D820ALAYXFNT0 ()
  • D820ALAYXFNT3 ()
  • D820ALAYXFNT2 ()
  • D820ALAYXFNT1 ()
ALAYXFNT

  • Dental pit/fissure sealant

AuraLay Pit and Fissure Sealant - D820ALAYOW0

Pit and Fissure Sealant, Dental.
DENALI CORPORATION
Opaque White
In Commercial Distribution

  • D820ALAYOW0 ()
  • D820ALAYOW3 ()
  • D820ALAYOW2 ()
  • D820ALAYOW1 ()


  • Dental pit/fissure sealant

AuraLay Pit & Fissure Sealant - D820ALAYNT0

Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Natural Translucent
In Commercial Distribution

  • D820ALAYNT0 ()
  • D820ALAYNT1 ()
  • D820ALAYNT3 ()
  • D820ALAYNT2 ()
ALAYNT

  • Dental pit/fissure sealant

ORTHOSOURCE - D9115670410

Blue Etch 1.2 cc syringe
ORTHOSOURCE
567-041
In Commercial Distribution

  • D911557041503 ()
  • D9115670410 ()
  • D911567041202 ()
  • D91156704141 ()


  • Dental etching solution

ORTHOSOURCE - D9115670400

Red Etch 1.2 cc syringe
ORTHOSOURCE
567-040
In Commercial Distribution

  • D911557040503 ()
  • D9115670400 ()
  • D911567040202 ()
  • D91156704041 ()


  • Dental etching solution

Generic - D830551442PC9

TYVEK ROLL 12"X200'
AMD Medicom Inc
551442PC
In Commercial Distribution

  • D830551442PC0 ()
  • D830551442PC9 ()
  • D830551442PC8 ()
  • D830551442PC7 ()


  • Sterilization packaging, single-use

Generic - D830551436PC9

TYVEK ROLL 6"X200'
AMD Medicom Inc
551436PC
In Commercial Distribution

  • D830551436PC0 ()
  • D830551436PC9 ()
  • D830551436PC8 ()
  • D830551436PC6 ()


  • Sterilization packaging, single-use

coDiagnostiX - D835CODX1

Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation

coDiagnostiX - D835CDX1

Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation

Plasdent Clear Protection Sterilization Pouch - D832POH71213

Autoclave Pouches 7 1/2" x 13", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH712135 ()
  • D832POH71213 ()
  • D832POH712131 ()
  • D832POH712132 ()
POH712-13

  • Sterilization packaging, single-use

Plasdent Clear Protection Sterilization Pouch - D832POH51410

Autoclave Pouches 5 1/4" x 10", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH514105 ()
  • D832POH51410 ()
  • D832POH514101 ()
  • D832POH514102 ()
POH514-10

  • Sterilization packaging, single-use

Plasdent Clear Protection Sterilization Pouch - D832POH41412

Autoclave Pouches 4 1/4" x 12", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH414125 ()
  • D832POH41412 ()
  • D832POH414121 ()
  • D832POH414122 ()
POH414-12

  • Sterilization packaging, single-use

Plasdent Clear Protection Sterilization Pouch - D832POH3129

Autoclave Pouches 3 1/2" x 9", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH31295 ()
  • D832POH3129 ()
  • D832POH31291 ()
  • D832POH31292 ()
POH312-9

  • Sterilization packaging, single-use

Plasdent Clear Protection Sterilization Pouch - D832POH312514

Autoclave Pouches 3 1/2" x 5 1/4", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH3125145 ()
  • D832POH312514 ()
  • D832POH3125141 ()
  • D832POH3125142 ()
POH312-514

  • Sterilization packaging, single-use

Plasdent Clear Protection Sterilization Pouch - D832POH29

Autoclave Pouches 2" x 9", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH295 ()
  • D832POH29 ()
  • D832POH291 ()
  • D832POH292 ()
POH2-9

  • Sterilization packaging, single-use

Plasdent Clear Protection Sterilization Pouch - D832POH2349

Autoclave Pouches 2 3/4" x 9", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH23495 ()
  • D832POH2349 ()
  • D832POH23491 ()
  • D832POH23492 ()
POH234-9

  • Sterilization packaging, single-use

Plasdent Clear Protection Sterilization Pouch - D832POH2144

Autoclave Pouches 2 1/4" x 4", Dual Indicator (200pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH21445 ()
  • D832POH2144 ()
  • D832POH21441 ()
  • D832POH21442 ()
POH214-4

  • Sterilization packaging, single-use

Plasdent Clear Protection Sterilization Pouch - D832POH1215

Autoclave Pouches 12" x 15", Dual Indicator (100pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH12155 ()
  • D832POH1215 ()
  • D832POH12151 ()
  • D832POH12152 ()
POH12-15

  • Sterilization packaging, single-use

Plasdent Clear Protection Sterilization Pouch - D832POH1015

Autoclave Pouches 10" x 15", Dual Indicator (100pcs/box)
PLASDENT CORPORATION
POH
In Commercial Distribution

  • D832POH10155 ()
  • D832POH1015 ()
  • D832POH10151 ()
  • D832POH10152 ()
POH10-15

  • Sterilization packaging, single-use

Plasdent ULTRAPROOF Earloop Mask - D832MKS32

ULTRAPROOF (TM) Earloop Mask with Shield- Pink (25pcs/box)
PLASDENT CORPORATION
MKS1
In Commercial Distribution

  • D832MKS325 ()
  • D832MKS32 ()
  • D832MKS321 ()
  • D832MKS322 ()
MKS3-2

  • Surgical/medical respirator, antimicrobial

Plasdent FluidProof Earloop Mask - D832MKS16

FLUIDPROOF (TM) Earloop Mask with Shield- Pink (25pcs/box)
PLASDENT CORPORATION
MKS1
In Commercial Distribution

  • D832MKS165 ()
  • D832MKS16 ()
  • D832MKS161 ()
  • D832MKS162 ()
MKS1-6

  • Surgical/medical respirator, antimicrobial

Plasdent FluidProof Earloop Mask - D832MKS12

FLUIDPROOF (TM) Earloop Mask with Shield- Blue (25pcs/box)
PLASDENT CORPORATION
MKS1
In Commercial Distribution

  • D832MKS125 ()
  • D832MKS12 ()
  • D832MKS121 ()
  • D832MKS122 ()
MKS1-2

  • Surgical/medical respirator, antimicrobial

Plasdent UltraProof Earloop Mask - D832MK32

DuralProof(TM) Earloop Face Mask - Blue (40pcs/box)
PLASDENT CORPORATION
MK2
In Commercial Distribution

  • D832MK325 ()
  • D832MK32 ()
  • D832MK321 ()
  • D832MK322 ()
MK3-2

  • Surgical/medical respirator, antimicrobial

Plasdent Fluid Proof Earloop Mask - D832MK16

FLUIDPROOF (TM) Earloop Mask - Pink (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK165 ()
  • D832MK16 ()
  • D832MK161 ()
  • D832MK162 ()
MK1-6

  • Surgical/medical respirator, antimicrobial

Plasdent Fluid Proof Earloop Mask - D832MK14

FLUIDPROOF (TM) Earloop Mask - Green (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK145 ()
  • D832MK14 ()
  • D832MK141 ()
  • D832MK142 ()
MK1-4

  • Surgical/medical respirator, antimicrobial

Plasdent Fluid Proof Earloop Mask - D832MK13

FLUIDPROOF (TM) Earloop Mask - Yellow (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK135 ()
  • D832MK13 ()
  • D832MK131 ()
  • D832MK132 ()
MK1-3

  • Surgical/medical respirator, antimicrobial

Plasdent Fluid Proof Earloop Mask - D832MK12

FLUIDPROOF (TM) Earloop Mask - Blue (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK125 ()
  • D832MK12 ()
  • D832MK121 ()
  • D832MK122 ()
MK1-2

  • Surgical/medical respirator, antimicrobial

Plasdent Fluid Proof Earloop Mask - D832MK110

FLUIDPROOF (TM) Earloop Mask - Lavender (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK1101 ()
  • D832MK110 ()
  • D832MK1105 ()
  • D832MK1102 ()
MK1-10L

  • Surgical/medical respirator, antimicrobial

Plasdent Fluid Proof Earloop Mask - D832MK11

FLUIDPROOF (TM) Earloop Mask - White (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

  • D832MK115 ()
  • D832MK11 ()
  • D832MK111 ()
  • D832MK112 ()
MK1-1

  • Surgical/medical respirator, antimicrobial

FlexTube 3 single use - EFIAE0131041

The product is a single use navigated suction instrument for image guided surgical procedures. The instruments are intended as an aid for locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
In Commercial Distribution

  • EFIAE0131042 ()
  • EFIAE0131041 ()
  • EFIAE0131043 ()
  • EFIAE0131044 ()


  • ENT stereotactic surgery system

FlexPointer 1.5 single use - EFIAE0130041

The product FlexPointer 1.5 single use is navigated pointer probe for image guided surgical procedures The instruments are intended as an aid for locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
In Commercial Distribution

  • EFIAE0130041 ()
  • EFIAE0130042 ()
  • EFIAE0130043 ()
  • EFIAE0130044 ()
E 01 3004

  • ENT stereotactic surgery system

Axiom® Lig-A-Boots® - M6653010

Instrument Jaw Covers, Multi-Color Pack
AXIOM MEDICAL, INCORPORATED
301
In Commercial Distribution

  • M6653013 ()
  • M6653011 ()
  • M6653010 ()
  • M6653015 ()


  • Vascular booties

Axiom® Lig-A-Loops® - M6651180

Retraction Tape, Mini, Blue, Veins
AXIOM MEDICAL, INCORPORATED
118
In Commercial Distribution

  • M6651185 ()
  • M6651183 ()
  • M6651181 ()
  • M6651180 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651170

Retraction Tape, Mini, White, Nerves
AXIOM MEDICAL, INCORPORATED
117
In Commercial Distribution

  • M6651175 ()
  • M6651173 ()
  • M6651171 ()
  • M6651170 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651160

Retraction Tape, Mini, Yellow, Ureters
AXIOM MEDICAL, INCORPORATED
116
In Commercial Distribution

  • M6651165 ()
  • M6651163 ()
  • M6651161 ()
  • M6651160 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651150

Retraction Tape, Mini, Red, Arteries
AXIOM MEDICAL, INCORPORATED
115
In Commercial Distribution

  • M6651155 ()
  • M6651153 ()
  • M6651151 ()
  • M6651150 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651140

Retraction Tape, Maxi, Blue, Veins
AXIOM MEDICAL, INCORPORATED
114
In Commercial Distribution

  • M6651145 ()
  • M6651143 ()
  • M6651141 ()
  • M6651140 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651130

Retraction Tape, Maxi, White, Nerves
AXIOM MEDICAL, INCORPORATED
113
In Commercial Distribution

  • M6651135 ()
  • M6651133 ()
  • M6651131 ()
  • M6651130 ()


  • Surgical support tape, non-bioabsorbable

Axiom® Lig-A-Loops® - M6651120

Retraction Tape, Maxi, Yellow, Ureters
AXIOM MEDICAL, INCORPORATED
112
In Commercial Distribution

  • M6651125 ()
  • M6651123 ()
  • M6651121 ()
  • M6651120 ()


  • Surgical support tape, non-bioabsorbable
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