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

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

  • Surgical/medical respirator, antimicrobial
FLUIDPROOF (TM) Earloop Mask - Pink (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

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

  • Surgical/medical respirator, antimicrobial
FLUIDPROOF (TM) Earloop Mask - Yellow (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

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

  • Surgical/medical respirator, antimicrobial
Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

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


  • Diagnostic x-ray digital imaging system workstation
Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

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


  • Diagnostic x-ray digital imaging system workstation
TYVEK ROLL 12"X200'
GS Medical Packaging Inc
551442PC
In Commercial Distribution

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


  • Sterilization packaging, single-use
TYVEK ROLL 6"X200'
GS Medical Packaging Inc
551436PC
In Commercial Distribution

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


  • Sterilization packaging, single-use
Alginate Alternative 380 Fast Set 2/pk. - MARK3®*
CARGUS INTERNATIONAL, INC
9013
In Commercial Distribution

  • D7969013 ()
  • D79690131 ()
  • D79690132 ()
  • D79690133 ()
  • D79690134 ()
9013

  • Silicone dental impression material
Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Opaque White
In Commercial Distribution

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

  • Dental pit/fissure sealant
Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Natural Translucent
In Commercial Distribution

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

  • Dental pit/fissure sealant
Pit and Fissure Sealant, Dental.
DENALI CORPORATION
Opaque White
In Commercial Distribution

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


  • Dental pit/fissure sealant
Pit and Fissure Sealant, Dental.
DENALI CORPORATION
1.2 mL Natural Translucent
In Commercial Distribution

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

  • Dental pit/fissure sealant
Blue Etch 1.2 cc syringe
ORTHOSOURCE
567-041
In Commercial Distribution

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


  • Dental etching solution
Red Etch 1.2 cc syringe
ORTHOSOURCE
567-040
In Commercial Distribution

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


  • Dental etching solution
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
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
The ERG-Jet is a contact lens for performing an electroretinogram, or ERG, provocated by light stimulation of the retina in either humans or animals. The electrode is made of a gold ring just a few angstroms (10-10 meter) thick, which can be safely placed in contact with the cornea using a viscous conductive liquid.
Fabrinal SA
F06
In Commercial Distribution

  • EFABF061 ()
  • EFABF062 ()
  • EFAB0612 ()
  • EFABF063 ()

  • Electrical resistance: approx. 12 Ohms
  • Light transmission: 91.4%
  • Neutral optic quality
  • Female connection: DIN 1.50 Millimeter
  • Radius of curvature: 7.90 Millimeter
  • Outer Diameter: 12 Millimeter


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

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

  • Surgical/medical respirator, antimicrobial
FLUIDPROOF (TM) Earloop Mask - Blue (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

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

  • Surgical/medical respirator, antimicrobial
FLUIDPROOF (TM) Earloop Mask - Lavender (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

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

  • Surgical/medical respirator, antimicrobial
FLUIDPROOF (TM) Earloop Mask - White (50pcs/box)
PLASDENT CORPORATION
MK1
In Commercial Distribution

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

  • Surgical/medical respirator, antimicrobial
The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 6Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
800-612C
In Commercial Distribution

  • M729800612C2 ()
  • M729800612C0 ()
  • M729800612C1 ()
  • M729800612C3 ()

  • Catheter Gauge: 6 to 12 French


  • Femoral artery closure plug/patch, collagen
No Description
BIOTEX, INC.
SL-12
In Commercial Distribution

  • M710SL122 ()
  • M710SL120 ()
  • M710SL124 ()
SL-12

  • Operating room light
The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 235 cm.
SLATER ENDOSCOPY LLC
ES26235
In Commercial Distribution

  • M707ES26235 ()
  • M707ES262351 ()
  • M707ES262350 ()

  • Length: 235 Centimeter
  • Outer Diameter: 2.6 Millimeter
ES26235

  • Flexible endoscopic scissors, single-use
The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 165 cm.
SLATER ENDOSCOPY LLC
ES26165
In Commercial Distribution

  • M707ES26165 ()
  • M707ES261651 ()
  • M707ES261650 ()

  • Length: 165 Centimeter
  • Outer Diameter: 2.6 Millimeter
ES26165

  • Flexible endoscopic scissors, single-use
Sump Drain Suture Ring Dual-Sump
AXIOM MEDICAL, INCORPORATED
999090
In Commercial Distribution

  • M6659990903 ()
  • M6659990901 ()
  • M6659990900 ()


  • Sump drain
Closed Wound Drain, Round, Silicone, With Trocar, With ClotStop®
AXIOM MEDICAL, INCORPORATED
803645AT
In Commercial Distribution

  • M665803645AT3 ()
  • M665803645AT1 ()
  • M665803645AT0 ()

  • 19 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With Trocar
AXIOM MEDICAL, INCORPORATED
803645
In Commercial Distribution

  • M6658036453 ()
  • M6658036451 ()
  • M6658036450 ()

  • 19 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With Trocar, With ClotStop®
AXIOM MEDICAL, INCORPORATED
803643AT
In Commercial Distribution

  • M665803643AT3 ()
  • M665803643AT1 ()
  • M665803643AT0 ()

  • 15 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With Trocar
AXIOM MEDICAL, INCORPORATED
803643
In Commercial Distribution

  • M6658036433 ()
  • M6658036431 ()
  • M6658036430 ()

  • 15 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With Trocar, With ClotStop®
AXIOM MEDICAL, INCORPORATED
803642AT
In Commercial Distribution

  • M665803642AT3 ()
  • M665803642AT1 ()
  • M665803642AT0 ()

  • 10 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With Trocar
AXIOM MEDICAL, INCORPORATED
803642
In Commercial Distribution

  • M6658036423 ()
  • M6658036421 ()
  • M6658036420 ()

  • 10 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With Trocar, With ClotStop®
AXIOM MEDICAL, INCORPORATED
803641AT
In Commercial Distribution

  • M665803641AT3 ()
  • M665803641AT1 ()
  • M665803641AT0 ()

  • 12 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With Trocar
AXIOM MEDICAL, INCORPORATED
803641
In Commercial Distribution

  • M6658036413 ()
  • M6658036411 ()
  • M6658036410 ()

  • 12 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With Trocar, With ClotStop®
AXIOM MEDICAL, INCORPORATED
803640AT
In Commercial Distribution

  • M665803640AT3 ()
  • M665803640AT1 ()
  • M665803640AT0 ()

  • 7 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Round, Silicone, With Trocar
AXIOM MEDICAL, INCORPORATED
803640
In Commercial Distribution

  • M6658036403 ()
  • M6658036401 ()
  • M6658036400 ()

  • 7 FR


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Flat, Silicone, With Trocar, With ClotStop®
AXIOM MEDICAL, INCORPORATED
803631AT
In Commercial Distribution

  • M665803631AT3 ()
  • M665803631AT1 ()
  • M665803631AT0 ()

  • 7 mm


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Flat, Silicone, With Trocar
AXIOM MEDICAL, INCORPORATED
803631
In Commercial Distribution

  • M6658036313 ()
  • M6658036311 ()
  • M6658036310 ()

  • 7 mm


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Flat, Silicone, With Trocar, With ClotStop®
AXIOM MEDICAL, INCORPORATED
803626AT
In Commercial Distribution

  • M665803626AT3 ()
  • M665803626AT1 ()
  • M665803626AT0 ()

  • 10 mm


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Flat, Silicone, With Trocar
AXIOM MEDICAL, INCORPORATED
803626
In Commercial Distribution

  • M6658036263 ()
  • M6658036261 ()
  • M6658036260 ()

  • 10 mm


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Flat, Silicone, With Trocar, With ClotStop®
AXIOM MEDICAL, INCORPORATED
803621AT
In Commercial Distribution

  • M665803621AT3 ()
  • M665803621AT1 ()
  • M665803621AT0 ()

  • 13 mm


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Flat, Silicone, With Trocar
AXIOM MEDICAL, INCORPORATED
803621
In Commercial Distribution

  • M6658036213 ()
  • M6658036211 ()
  • M6658036210 ()

  • 13 mm


  • Closed-wound drain, non-bioabsorbable
Closed Wound Drain, Flat, Silicone, With Trocar, With ClotStop®
AXIOM MEDICAL, INCORPORATED
800410AT
In Commercial Distribution

  • M665800410AT3 ()
  • M665800410AT1 ()
  • M665800410AT0 ()

  • 4 mm


  • Closed-wound drain, non-bioabsorbable
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