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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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Integra® Proximal Humeral Fracture Plate System - 10381780120902

The locking screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS2710LS
In Commercial Distribution

  • 10381780120902 ()
  • M269PSS2710LS1 ()

  • .536 in L x .106 in dia
PSS2710LS

  • Surgical soft-tissue manipulation forceps, alligator, reusable

NeoBar® - 00812594011849

The NeoBar is intended to secure an endotracheal tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Assorted
In Commercial Distribution

  • 00812594010118 ()
  • 00812594011849 ()
N719N

  • Endotracheal tube holder

NeoBar® - 00812594011832

The NeoBar is intended to secure an endotracheal tube. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Neobar Transport Box
In Commercial Distribution

  • 00812594010118 ()
  • 00812594011832 ()
N718

  • Endotracheal tube holder

NIOX - 07350047030366

This is a rechargeable Li-Ion replacement battery for the NIOX VERO that is charged via the power supply or USB port.
Circassia AB
VERO Battery
In Commercial Distribution

  • 07350047030366 ()
12-1150

  • Nitrogen monoxide analyser

Capo Universal, 6 g - ESDG2320541

Capo Universal is a light-curing composite containing an ultrafine, radiopaque glass filler and is indicated for placing fillings using adhesive techniques.
Schütz Dental GmbH
232054
In Commercial Distribution

  • ESDG2320541 ()


  • Dental composite resin

FUSION-Zr - Veneer Cement - D8370655200

FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired.
Taub Products
New White - 0.6mL - Sample
In Commercial Distribution

  • D8370655200 ()

  • Total Volume: 0.6 Milliliter
06-5520

  • Dental composite resin

FUSION-Zr - Veneer Cement - D8370655100

FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired.
Taub Products
Opal White - 0.6mL - Sample
In Commercial Distribution

  • D8370655100 ()

  • Total Volume: 0.6 Milliliter
06-5510

  • Dental composite resin

FUSION-Zr - Veneer Cement - D8370655000

FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired.
Taub Products
Crystal Clear - 0.6mL - Sample
In Commercial Distribution

  • D8370655000 ()

  • Total Volume: 0.6 Milliliter
06-5500

  • Dental composite resin

FUSION-Zr - Veneer Cement - D8370651150

FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired.
Taub Products
Opal White - 3ml Syringe
In Commercial Distribution

  • D8370651150 ()

  • Total Volume: 3 Milliliter
06-5115

  • Dental composite resin

FUSION-Zr - Veneer Cement - D8370651050

FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired.
Taub Products
Crystal Clear - 3ml Syringe
In Commercial Distribution

  • D8370651050 ()

  • Total Volume: 3 Milliliter
06-5105

  • Dental composite resin

FUSION-Zr - Veneer Cement - D8370650300

FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired.
Taub Products
Kit - 2 New White - 1.2ml Syringe
Not in Commercial Distribution

  • D8370650300 ()

  • Total Volume: 1.2 Milliliter
06-5030

  • Dental composite resin

FUSION-Zr - Veneer Cement - D8370650200

FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired.
Taub Products
Kit - 2 Opal White - 1.2ml Syringe
In Commercial Distribution

  • D8370650200 ()

  • Total Volume: 1.2 Milliliter
06-5020

  • Dental composite resin

FUSION-Zr - Veneer Cement - D8370650100

FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired.
Taub Products
Kit - 2 Crystal Clear - 1.2ml Syringe
In Commercial Distribution

  • D8370650100 ()

  • Total Volume: 1.2 Milliliter
06-5010

  • Dental composite resin

FUSION-Zr - Veneer Cement - D8370650000

FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired.
Taub Products
Kit - 2 Clear/2 White - 1.2ml Syringe
Not in Commercial Distribution

  • D8370650000 ()

  • Total Volume: 1.2 Milliliter
06-5000

  • Dental composite resin

Gamma LO-ION - 10888234001775

Gamma LO-ION is intended as an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the ten (10) vial configuration.
IMMUCOR, INC.
0704610
In Commercial Distribution

  • 10888234001775 ()
0704610

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD

ImmuAdd - 10888234000167

ImmuAdd is intended for use as a potentiator in antibody detection, antibody identification and compatibility procedures. This product is prepared from glycine and salt-poor bovine albumin, and is the ten (10) vial configuration.
IMMUCOR, INC.
0002008
In Commercial Distribution

  • 10888234000167 ()
0002008

  • Bovine serum albumin (BSA) immunohaematology reagent IVD

Jointown - 00850017230002

Jointown Surigcal Face Mask is a class II medical device (product code FXX). It is a ASTM level 2 facemask. The smallest packaging unit with UDI is a paper box containing 50 pieces.
U.S. HEALTH EXPRESS CORP.
2082Blue
In Commercial Distribution

  • 00850017230026 ()
  • 00850017230002 ()
2082

  • Surgical/medical face mask, single-use

BRAEBON MediByte - B140MP8W0

The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a warranty replacement unit.
Braebon Medical Corporation
MP8-W
In Commercial Distribution

  • B140MP8W0 ()
MP8-W

  • Polysomnograph

Etchmaster - D798EMTRL1

The Etchmaster system is intended for use is for polishing, roughening and/or etching of tooth surfaces, enamel, dentin, and dental restorations for adhesive restorative procedures. This is the Etchmaster Regular Tip, Large
RELIANCE ORTHODONTIC PRODUCTS INC
EMTRL
In Commercial Distribution

  • D798EMTRL1 ()
  • D798EMTRL0 ()
EMTRL

  • Dental abrasive air jet system

Canady Plasma GIT Side Fire Probe - B413AW4225400

The Canady Hybrid Plasma GIT Side Fire probe is an electrosurgical plasma probe that is 2.3 mm in diameter and 2.3 m long. The electrosurgical plasma probe is used to coagulate biological tissue.
US MEDICAL INNOVATIONS, LLC
AW-422540
In Commercial Distribution

  • B413AW4225400 ()


  • Inert gas-enhanced endoscopic electrosurgical electrode, single-use

Trel X-Press 300 - 10381780112563

Trel-XPress 300, 2.5cc is made using demineralized human bone mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES325
In Commercial Distribution

  • M386XPRES3251 ()
  • 10381780112563 ()

  • 2.5cc
XPRES325

  • Bone matrix implant, human-derived

Trel X-Press 300 - 10381780112556

Trel-XPress 300, 5cc is made using demineralized human bone mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES305
In Commercial Distribution

  • M386XPRES3051 ()
  • 10381780112556 ()

  • 5cc
XPRES305

  • Bone matrix implant, human-derived

Trel X-Press 300 - 10381780112549

Trel-XPress 300, 10cc is made using demineralized human bone mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES310
In Commercial Distribution

  • 10381780112549 ()
  • M386XPRES3101 ()

  • 10cc
XPRES310

  • Bone matrix implant, human-derived

NaviCam Small Bowel Capsule Endoscopy System - 06921010800531

The Locator is a portable magnetic scanning device with built-in rechargeable lithium battery. It is used to turn the capsule on before it is swallowed by the patient and can be used for detecting whether a capsule is inside the human body and probing its approximate position.
ANKON Technologies Co.,Ltd.
Locator/AKS-1
In Commercial Distribution

  • 06921010800531 ()
SB-US-2006

  • Video capsule endoscopy monitoring kit

Acrylic Block - 14560227799116

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 232 mm length x 192 mm width x 35 mm depth, and the color type is Dark Pink.
SUN MEDICAL CO.,LTD.
MCL-013-M
Not in Commercial Distribution

  • 14560227799116 ()
  • 04560227799119 ()
  • 24560227799113 ()

  • Depth: 35 Millimeter
  • Width: 192 Millimeter
  • Length: 232 Millimeter
TS33US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799109

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 232 mm length x 192 mm width x 35 mm depth, and the color type is Pink.
SUN MEDICAL CO.,LTD.
MCL-011-M
Not in Commercial Distribution

  • 14560227799109 ()
  • 04560227799102 ()
  • 24560227799106 ()

  • Depth: 35 Millimeter
  • Width: 192 Millimeter
  • Length: 232 Millimeter
TS32US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799093

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 232 mm length x 192 mm width x 35 mm depth, and the color type is Light Pink.
SUN MEDICAL CO.,LTD.
MCL-010-M
Not in Commercial Distribution

  • 14560227799093 ()
  • 04560227799096 ()
  • 24560227799090 ()

  • Depth: 35 Millimeter
  • Width: 192 Millimeter
  • Length: 232 Millimeter
TS31US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799086

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cylindrical shaped product is 98.5 mm diameter x 30 mm depth, and the color type is Dark Pink.
SUN MEDICAL CO.,LTD.
MCL-013-C
Not in Commercial Distribution

  • 14560227799086 ()
  • 04560227799089 ()
  • 24560227799083 ()

  • Depth: 30 Millimeter
  • Outer Diameter: 98.5 Millimeter
TS25US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799062

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cylindrical shaped product is 98.5 mm diameter x 30 mm depth, and the color type is Light Pink.
SUN MEDICAL CO.,LTD.
MCL-010-C
Not in Commercial Distribution

  • 14560227799062 ()
  • 04560227799065 ()
  • 24560227799069 ()

  • Depth: 30 Millimeter
  • Outer Diameter: 98.5 Millimeter
TS21US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799024

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 109 mm length x 109 mm width x 35 mm depth. The model of color is Dark Pink.
SUN MEDICAL CO.,LTD.
MCL-013-A
Not in Commercial Distribution

  • 14560227799024 ()
  • 04560227799027 ()
  • 24560227799021 ()

  • Depth: 35 Millimeter
  • Width: 109 Millimeter
  • Length: 109 Millimeter
TS05US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799017

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 109 mm length x 109 mm width x 35 mm depth. The model of color is Pink.
SUN MEDICAL CO.,LTD.
MCL-011-A
Not in Commercial Distribution

  • 14560227799017 ()
  • 04560227799010 ()
  • 24560227799014 ()

  • Depth: 35 Millimeter
  • Width: 109 Millimeter
  • Length: 109 Millimeter
TS03US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799000

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 109 mm length x 109 mm width x 35 mm depth. The model of color is Light Pink.
SUN MEDICAL CO.,LTD.
MCL-010-A
Not in Commercial Distribution

  • 14560227799000 ()
  • 04560227799003 ()
  • 24560227799007 ()

  • Depth: 35 Millimeter
  • Width: 109 Millimeter
  • Length: 109 Millimeter
TS01US

  • Dental appliance fabrication material, thermoplastic

Epredia - 00673693270427

ClearVue™ Mountant is a toluene-based rapid-drying mounting medium. It is miscible with all clearing agents including xylene substitutes. This mounting medium is optically clear and will not cause fading of stains even after prolonged storage. ClearVue Mountant is approved specifically for use with the ClearVue coverslipper.
RICHARD-ALLAN SCIENTIFIC COMPANY
ClearVue™ Mountant
In Commercial Distribution

  • 00673693270427 ()
4211

  • Microscopy mounting medium IVD

XTHERMA - 08809709380466

10THERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
XTHERMA-H/P
In Commercial Distribution

  • 08809709380466 ()


  • Electrosurgical system

XTHERMA - 08809709380459

XTHERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
XTHERMA-Body
In Commercial Distribution

  • 08809709380459 ()


  • Electrosurgical system

10THERMA - 08809709380343

10THERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
TENTECH Inc.
TMSY02
In Commercial Distribution

  • 08809709380343 ()


  • Electrosurgical system

White PVA Foam Large - 00849405035138

The PVA Foam is a Polyvinyl Alcohol that comes pre moistened with sterile water. It is a less adherent high tensile strength material that helps to promote grafts and is easy to place and remove from tunnels and undermined areas. It is a non-invasive, non-implantable medical device.
GENADYNE BIOTECHNOLOGIES INC.
XF-PVALFOAM1
In Commercial Distribution

  • 00849405035138 ()

  • Length: 20 Centimeter
  • Width: 15 Centimeter
  • Depth: 1 Centimeter


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

White PVA Foam Medium - 00849405035121

The PVA Foam is a Polyvinyl Alcohol that comes pre moistened with sterile water. It is a less adherent high tensile strength material that helps to promote grafts and is easy to place and remove from tunnels and undermined areas. It is a non-invasive, non-implantable medical device.
GENADYNE BIOTECHNOLOGIES INC.
XF-PVAFOAM1
In Commercial Distribution

  • 00849405035121 ()

  • Length: 15 Centimeter
  • Width: 10 Centimeter
  • Depth: 1 Centimeter


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

White PVA Foam Small - 00849405035114

The PVA Foam is a Polyvinyl Alcohol that comes pre moistened with sterile water. It is a less adherent high tensile strength material that helps to promote grafts and is easy to place and remove from tunnels and undermined areas. It is a non-invasive, non-implantable medical device.
GENADYNE BIOTECHNOLOGIES INC.
XF-PVASFOAM1
In Commercial Distribution

  • 00849405035114 ()

  • Length: 7.5 Centimeter
  • Width: 10 Centimeter
  • Depth: 1 Centimeter


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

O2Vent Optima - 09351567000363

The O2Vent OptimaMini is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.
OVENTUS MANUFACTURING PTY LTD
O2Vent Optima Mini
In Commercial Distribution

  • 09351567000363 ()
O2VBM

  • Mandible-repositioning sleep-disordered breathing orthosis
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