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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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InoMesh - MDLXMAG120200

MAG1-2020: 20cm x 20cm (8in x 8in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-2020
In Commercial Distribution

  • MDLXMAG120200 ()
  • MDLXMAG120203 ()
  • MDLXMAG120202 ()
  • MDLXMAG120201 ()
MAG1-2020

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG115150

MAG1-1515: 15cm x 15cm (6in x 6in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1515
In Commercial Distribution

  • MDLXMAG115150 ()
  • MDLXMAG115153 ()
  • MDLXMAG115152 ()
  • MDLXMAG115151 ()
MAG1-1515

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

BE 102 Swivel Tubing Clamp - M996BE1020

Ventilator Tubing Accessory - Swivel Tubing Clamp. Swivels 360 degrees; fits tubing and rails 1/2" to 1" inch diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 102
In Commercial Distribution

  • M996BE1026 ()
  • M996BE1020 ()
  • M996BE1025 ()
  • M996BE1023 ()
BE 102

  • Ventilator breathing circuit, single-use

InoMesh - MDLXMAG120300

MAG1-2030: 20cm x 30cm (8in x 12in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-2030
In Commercial Distribution

  • MDLXMAG120300 ()
  • MDLXMAG120303 ()
  • MDLXMAG120302 ()
  • MDLXMAG120301 ()
MAG1-2030

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG115200

MAG1-1520: 15cm x 20cm (6in x 8in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1520
In Commercial Distribution

  • MDLXMAG115200 ()
  • MDLXMAG115203 ()
  • MDLXMAG115202 ()
  • MDLXMAG115201 ()
MAG1-1520

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

InoMesh - MDLXMAG115100

MAG1-1510: 15cm x 10cm (6in x 4in) Mesh Hernia Mesh Polyvinylidene fluoride/Polybutylene adipate
MEDLINX ACACIA PTE. LTD.
MAG1-1510
In Commercial Distribution

  • MDLXMAG115100 ()
  • MDLXMAG115103 ()
  • MDLXMAG115102 ()
  • MDLXMAG115101 ()
MAG1-1510

  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

BE 125-1TD Disposable Tee Adapter - M996BE1251TD0

The BE 125-1TD Tee Adapter is intended for use in a ventilator, oxygen or BIPAP circuit. Can be used to easily add a monitoring device such as a temperature probe to the breathing circuit. Dimensions: 22mm O.D. x 22mm I.D. x 15mm I.D. Single Patient Use. Molded of High Density Polyethylene.
INSTRUMENTATION INDUSTRIES, INCORPORATED
BE 125-1TD
In Commercial Distribution

  • M996BE1251TD6 ()
  • M996BE1251TD0 ()
  • M996BE1251TD3 ()
  • M996BE1251TD2 ()
BE 125-1TD

  • Straight/elbow breathing circuit connector, single-use

QuickProfile™ Amphetamine Test Card - M90174014

Immunoassay for the detection of amphetamine in human urine
LUMIQUICK DIAGNOSTICS, INC.
74014
In Commercial Distribution

  • M90174014 ()
  • M901740141 ()
  • M901740143 ()
  • M901740142 ()

  • Length: 75 Millimeter
74014

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

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

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

ERG-Jet - EFABF062

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

Generic - D830551442PC9

TYVEK ROLL 12"X200'
GS Medical Packaging Inc
551442PC
In Commercial Distribution

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


  • Sterilization packaging, single-use

Generic - D830551436PC9

TYVEK ROLL 6"X200'
GS Medical Packaging Inc
551436PC
In Commercial Distribution

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


  • Sterilization packaging, single-use

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 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 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 - 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 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 - 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 - 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 - D832MK11

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

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

  • Surgical/medical respirator, antimicrobial

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

ORTHOSOURCE - D9115670410

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

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


  • Dental etching solution
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