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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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Resin-based dental restorative material ; DenFil A4 4g x 1 syringe
VERICOM CO., LTD.
DF104-RA44
In Commercial Distribution

  • 08809254450041 ()


  • Dental composite resin
Resin-based dental restorative material ; DenFil A3.5 4g x 1 syringe
VERICOM CO., LTD.
DF104-RA35
In Commercial Distribution

  • 08809254450034 ()


  • Dental composite resin
Resin-based dental restorative material ; DenFil A3 4g x 1 syringe
VERICOM CO., LTD.
DF104-RA33
In Commercial Distribution

  • 08809254450027 ()


  • Dental composite resin
Resin-based dental restorative material ; DenFil A2 4g x 1 syringe
VERICOM CO., LTD.
DF104-RA22
In Commercial Distribution

  • 08809254450010 ()


  • Dental composite resin
Resin-based dental restorative material ; DenFil A1 4g x 1 syringe
VERICOM CO., LTD.
DF104-RA11
In Commercial Distribution

  • 08809254450003 ()


  • Dental composite resin
XmaruView V1 is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. XmaruView V1 performs connects with flat-panel detectors and generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. XmaruView V1 provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography.
Rayence Co., Ltd.
XmaruView V1
In Commercial Distribution

  • 08800018600610 ()


  • Basic diagnostic x-ray system application software
Xmaru Chiroview is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. Xmaru Chiroview performs connects with flat-panel detectors and generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. Xmaru Chiroview provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography.
Rayence Co., Ltd.
Xmaru Chiroview
In Commercial Distribution

  • 08800018600603 ()


  • Basic diagnostic x-ray system application software
Xmaru Podview is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. Xmaru Podview performs connects with flat-panel detectors and generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. Xmaru Podview provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography.
Rayence Co., Ltd.
Xmaru Podview
In Commercial Distribution

  • 08800018600597 ()


  • Basic diagnostic x-ray system application software
Xmaru Pro software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, measurements, automated measurement of bone age from a child's hand X-ray, and function to assist the image reading by detecting abnormal areas on the chest X-ray. Xmaru Pro is complying with DICOM standards to assure optimum communications between network systems. (not approved for mammography) Xmaru Pro offered as a stand-alone imaging solution to be installed in a PC for trained medical professionals.
Rayence Co., Ltd.
Xmaru Pro
In Commercial Distribution

  • 08800018600580 ()


  • Basic diagnostic x-ray system application software
ClearON Mobile provides easy touch based user interface to perform diagnosis of digital radiograph images displayed on ClearOn Mobile. ClearON Mobile receives digital images from a flat panel detector and a X-ray generator. The software also manages patient data, stores and transfers diagnostic images in an internal database.  It supports DICOM image file format which allows interoperability with other Radiography equipment in network environment.  
Rayence Co., Ltd.
ClearON Mobile
In Commercial Distribution

  • 08800018600573 ()


  • Basic diagnostic x-ray system application software
Xmaru PACS is a software program designed to provide image acquisition, processing and operational management functions for Digital Radiography.
Rayence Co., Ltd.
Xmaru PACS
In Commercial Distribution

  • 08800018600429 ()


  • Basic diagnostic x-ray system application software
XmaruView V1 is a radiographic image acquisition and image data management program in charge of variety of image related functions, including photographing Digital Radiography, acquiring and processing the images, and the image management
Rayence Co., Ltd.
XmaruView V1
In Commercial Distribution

  • 08800018600399 ()


  • Basic diagnostic x-ray system application software
No Description
GENORAY CO., LTD.
Triana
In Commercial Distribution

  • 08809244060144 ()


  • General-purpose dental x-ray system application software
Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)).
ASCENSIA DIABETES CARE US INC.
7283
Not in Commercial Distribution

  • 40301937283350 ()
  • 00301937283352 ()
  • 0193-7283-35 ()
  • 00301937283017 ()
84698032

  • Glucose monitoring system IVD, home-use
FIZE kUO Disposable Adult kit, Urinemeter catalog number of 1 pc: FI-KT00-KU01-0010 FIZE kUO Disposable Adult kit, Urinemeter catalog number of 20 pcs: FI-FG00-KU03-0005
FIZE RESEARCH LTD
G2
In Commercial Distribution

  • 17290019239298 ()
  • 07290019239291 ()
FI-KT00-KU01-0010

  • Urine monitoring system
FIZE kUO Disposable Pediatrics kit, Urinemeter catalog number of 1 pc: FI-KT00-KU01-0011 FIZE kUO Disposable Pediatrics kit,Urinemeter catalog number of 20 pcs: FI-FG00-KU03-0006
FIZE RESEARCH LTD
G2
In Commercial Distribution

  • 17290019239281 ()
  • 07290019239284 ()
FI-KT00-KU01-0011

  • Urine monitoring system
FIZE kUO Disposable Pediatrics kit, Urinometer catalog number for 1 pc: FI-KTUS-KU01-0155 FIZE kUO Disposable Pediatrics kit, Urinometer catalog number for 20 pcs: FI-FGUS-KU03-0028
FIZE RESEARCH LTD
G1
In Commercial Distribution

  • 17290019239229 ()
  • 07290019239222 ()
  • 07290019239253 ()
FI-KTUS-KU01-0155

  • Urine monitoring system
15 Fr. x 27 cm NextStep(R) Antegrade Hemodialysis Catheterization Set, Long-Term Access Catheter Length, Tip to Cuff: 27 cm
TELEFLEX INCORPORATED
IPN032565
In Commercial Distribution

  • 10801902072938 ()
  • 00801902072931 ()
  • 30801902072932 ()

  • Catheter Gauge: 15 French
  • Length: 27 Centimeter
AC-15272-SFX

  • Double-lumen haemodialysis catheter, implantable
Blanks (button blanks for use in the manufacture of RGP contact lenses) Color: Blue, Green, Brown, or Gray Number of Units
LIFESTYLE CO INC, THE
telefocon A
In Commercial Distribution

  • 00830002001015 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
No Description
IMEDICOM CO., LTD.
BR EZX Kit 27
In Commercial Distribution

  • 08800038040274 ()


  • Sawing power tool attachment, sagittal
  • Bone/joint surgical power tool motor, electric
No Description
IMEDICOM CO., LTD.
BR EZX Kit 27
In Commercial Distribution

  • 08800038035966 ()


  • Sawing power tool attachment, sagittal
  • Bone/joint surgical power tool motor, electric
Absorbent Paper Points, Length Marked 02 Taper 90/140, 100 Points, P 21
Meta Biomed Co., Ltd.
2887
In Commercial Distribution

  • 08806387828877 ()


  • Endodontic paper point
Absorbent Paper Points, Length Marked 02 Taper 90/140, 100 Points, P 61
Meta Biomed Co., Ltd.
2538
In Commercial Distribution

  • 08806387825388 ()


  • Endodontic paper point
Absorbent Paper Points, Length Marked 02 Taper 90/140, 120 Points, P 71
Meta Biomed Co., Ltd.
2419
In Commercial Distribution

  • 08806387824190 ()


  • Endodontic paper point
Absorbent Paper Points, Length Marked 02 Taper 90/140, 100 Points, P 71
Meta Biomed Co., Ltd.
2276
In Commercial Distribution

  • 08806387822769 ()


  • Endodontic paper point
Absorbent Paper Points, Length Marked 02 Taper 90/140, 100 Points, P 31R
Meta Biomed Co., Ltd.
2760
In Commercial Distribution

  • 08806387827603 ()


  • Endodontic paper point
Absorbent Paper Points, length Marked 02 Taper 90/140, 100 Points, P 31S
Meta Biomed Co., Ltd.
2648
In Commercial Distribution

  • 08806387826484 ()


  • Endodontic paper point
Heating pad
WALGREEN CO.
000886-912-310U
Not in Commercial Distribution

  • 10311917186495 ()
  • 00311917186498 ()

  • Length: 18 Inch
000886-912-310U

  • Electric pad localized-body heating system
Heating pad
WALGREEN CO.
000886-912-583U
Not in Commercial Distribution

  • 10311917186488 ()
  • 00311917186481 ()

  • Length: 18 Inch
000886-912-583U

  • Electric pad localized-body heating system
Heating pad
WALGREEN CO.
002022-912-001U
In Commercial Distribution

  • 10311917185726 ()
  • 00311917185729 ()

  • Length: 24 Inch
002022-912-001U

  • Electric pad localized-body heating system
Heating pad
WALGREEN CO.
002021-912-001U
In Commercial Distribution

  • 10311917185719 ()
  • 00311917185712 ()

  • Length: 15 Inch
002021-912-001U

  • Electric pad localized-body heating system
Heating pad
WALGREEN CO.
000886-912-000U
In Commercial Distribution

  • 10311917178414 ()
  • 00311917178417 ()

  • Length: 18 Inch
000886-912-000U

  • Electric pad localized-body heating system
Heating pad
WALGREEN CO.
000535-912-001U
In Commercial Distribution

  • 10311917167609 ()
  • 00311917167602 ()

  • Length: 24 Inch
000535-912-001U

  • Electric pad localized-body heating system
Heating pad
WALGREEN CO.
000534-912-001U
In Commercial Distribution

  • 10311917167593 ()
  • 00311917167596 ()

  • Length: 15 Inch
000534-912-001U

  • Electric pad localized-body heating system
Platinum Radiographic / Fluoroscopic system 90/90 DRF43 FL with generator and X-Ray tube.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
RF6000
In Commercial Distribution

  • 00817100020100 ()


  • Stationary basic diagnostic x-ray system, digital
CURETTE, PERIODONTIC KIRSCH SINUS 5 "SMALL", LONG SHANK, ELEV./CURETTE 90°/90°/60°,
Helmut Zepf Medizintechnik GmbH
41.868.05SL
In Commercial Distribution

  • EZPF4186805SL0 ()
41.868.05SL

  • Periosteal elevator, reusable
Instrument Trays and Covers, Micro Tray with Lid, 90 x 90 x 50mm
KEY SURGICAL, INC.
Instrument Tray
In Commercial Distribution

MT5900

  • Instrument tray, reusable
Instrument Trays and Covers, Micro Tray with Lid, 90 x 90 x 50mm
KEY SURGICAL, INC.
MT-5900
Not in Commercial Distribution

  • 00849771005308 ()
MT5900

  • Instrument tray, reusable
UniPlex UPS 3/90, 0,70 x 90 mm with injection tubing + connecting cable
Pajunk GmbH Medizintechnologie
001151-31J
Not in Commercial Distribution

  • 14048223018030 ()
  • 04048223018033 ()
001151-31J

  • Nerve-locating anaesthesia needle
VAPR COOLPULSE 90 Electrode with Hand Controls 90 DEGREES Suction with Integrated Handpiece
DEPUY MITEK, LLC
228147
In Commercial Distribution

  • 10886705010097 ()
228147

  • Endoscopic electrosurgical electrode, bipolar, single-use
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