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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 - 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

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

Stradis Medical, LLC. - M752IN90090

Rope And Hook
STRADIS MEDICAL, LLC
IN9009
In Commercial Distribution

  • M752IN90095 ()
  • M752IN90090 ()
  • M752IN90093 ()
  • M752IN90096 ()


  • General surgical procedure kit, non-medicated, single-use

Stradis Medical, LLC - M752HCT1CCSFST0

1CC SLIP TIP SYRINGES SILICON FREE
STRADIS MEDICAL LLC
HCT1CCSF-ST
In Commercial Distribution

  • M752HCT1CCSFST5 ()
  • M752HCT1CCSFST1 ()
  • M752HCT1CCSFST0 ()
  • M752HCT1CCSFST6 ()


  • General-purpose syringe, single-use

Spetzler - OMT - M731100010

Neuro Pattie; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use.
OMT, LLC
Neuro Patties
In Commercial Distribution

  • M7311100169 ()
  • M731100010 ()
  • M7311100159 ()
  • K900005 ()
  • M7311100189 ()
ALL

  • Cottonoid pad

Cardiva VASCADE MVP VVCS 6-12F - M729800612C0

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

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

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

MARK3 - D79690131

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

MARK3 - D796116110

VPS Putty Fast Set 300ml. each Base & Catalyst - MARK3 EU
CARGUS INTERNATIONAL, INC
1161
In Commercial Distribution

  • D796116110 ()
  • D79611612 ()
  • D79611613 ()
  • D79611614 ()


  • Silicone dental impression material

MARK3 EU - D79611601

VPS Putty Regular Set 300ml. each Base & Catalyst - MARK3 EU
CARGUS INTERNATIONAL, INC
1160
In Commercial Distribution

  • D79611601 ()
  • D79611602 ()
  • D79611603 ()
  • D79611604 ()


  • Silicone dental impression material

MARK3 - D79611531

eXact VPS 380 Impression Material Monophase Regular Set 2/pk. - MARK3®*
CARGUS INTERNATIONAL, INC
1153
In Commercial Distribution

  • D7961153 ()
  • D79611531 ()
  • D79611532 ()
  • D79611533 ()
  • D79611534 ()
1153

  • Silicone dental impression material

MES 9000 Musculoskeletal System - D792N9000M0

Now you can have all of these capabilities in one compact system. Surface EMG, range of motion and muscle testing – may be purchased separately or in any combination. The modular design of the MES 9000 allows you to purchase any combination of modules and expand as your practice grows. The MES 9000 --- the modular system that enables you to do a complete, integrated evaluation with objective documentation that supports your diagnosis.
MYOTRONICS NOROMED, INC
N9000M
In Commercial Distribution

  • D792N91500 ()
  • D792N9000M0 ()
  • D792N92000 ()
  • D792N9200S0 ()


  • Virtual-display rehabilitation system, non-supportive, clinical

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

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

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

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
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