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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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KLOCKNER - 08435451655912

ANALOG PRO A-EC4 W
SOADCO, S.L.
88 001 18
In Commercial Distribution

  • 08435451655912 ()
88 001 18

  • Dental implant analog

KLOCKNER - 08435451655899

ANALOG PRO A-EC1 W
SOADCO, S.L.
88 001 16
In Commercial Distribution

  • 08435451655899 ()
88 001 16

  • Dental implant analog

KLOCKNER - 08435451655875

ANALOG PRO A-PV1
SOADCO, S.L.
88 001 14
In Commercial Distribution

  • 08435451655875 ()
88 001 14

  • Dental implant analog

APT 9 - 00887661274618

No Description
FGX INTERNATIONAL INC.
DL4144/88.KHL
In Commercial Distribution

  • 00887661274618 ()


  • Tinted non-prescription spectacles

UNBRANDED - 00887661319340

No Description
FGX INTERNATIONAL INC.
DL4148/88.SRS
In Commercial Distribution

  • 00887661319340 ()


  • Tinted non-prescription spectacles

ASSORTED BRANDS - 00887661314437

No Description
FGX INTERNATIONAL INC.
DL4207/88.FMY
In Commercial Distribution

  • 00887661314437 ()


  • Tinted non-prescription spectacles

ASSORTED BRANDS - 00887661574244

No Description
FGX INTERNATIONAL INC.
DL4619/88.CGR
In Commercial Distribution

  • 00887661574244 ()


  • Tinted non-prescription spectacles

MulTipeg™ - 07350096322085

No Description
Integration Diagnostics Sweden AB
MulTipeg™ 88
In Commercial Distribution

  • 07350096322085 ()
55122

  • Multimeter

Genoray - 08809244060144

No Description
GENORAY CO., LTD.
Triana
In Commercial Distribution

  • 08809244060144 ()


  • General-purpose dental x-ray system application software

Xmaru PACS - 08800018600429

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 - 08800018600399

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

XmaruView V1 - 08800018600610

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 - 08800018600603

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 - 08800018600597

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 - 08800018600580

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 - 08800018600573

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

ARROW - 00801902072931

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

Brasseler EZX - 08800038040274

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

EZX - 08800038035966

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

CONTOUR® NEXT - 00301937283352

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 - 07290019239291

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 - 07290019239284

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 - 07290019239222

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

Radiesse (+) Lidocaine 0.8cc Injectable Implant - M2138067M0K15

Radiesse (+) Lidocaine Injectable Implant is a volumizing filler with lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 0.8cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8067M0K1
In Commercial Distribution

  • M2138067M0K15 ()

  • Total Volume: 0.8 Milliliter


  • Dermal tissue reconstructive material, microbe-derived, anaesthetic

SGP - 00830002001015

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

UniPlex - 14048223018030

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 - 10886705010097

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

NA - 00849771048435

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

Key Surgical Trays - 00849771005308

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

HELMUT ZEPF - EZPF4186805SL0

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

Dynamic DR Room - 00817100020100

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

Portex - 15019517066692

No Description
ICU MEDICAL, INC.
A4264-25/27
In Commercial Distribution

  • 35019517066696 ()
  • 15019517066692 ()


  • Epidural anaesthesia set, medicated

Portex - 15019517094961

No Description
ICU MEDICAL, INC.
A4275-17/27
In Commercial Distribution

  • 35019517094965 ()
  • 15019517094961 ()


  • Epidural anaesthesia set, medicated

MaxMoreSpine - 04260200314017

Working Sleeve 11mm I.D
Hoogland Spine Products GmbH
1001-ES 27
In Commercial Distribution

  • 04260200314017 ()


  • Endoscope sheath, reusable

MANI MEDIUM FLEXILE FILES - 04546951504090

MANI K-FILES
MANI, INC.
25mm #27
In Commercial Distribution

  • 74546951504099 ()
  • 04546951504090 ()


  • Manual endodontic file/rasp, reusable

MANI MEDIUM FLEXILE FILES - 04546951504038

MANI K-FILES
MANI, INC.
21mm #27
In Commercial Distribution

  • 74546951504037 ()
  • 04546951504038 ()


  • Manual endodontic file/rasp, reusable

MANI MEDIUM H-FILES - 04546951503802

MANI H-FILES
MANI, INC.
25MM #27
In Commercial Distribution

  • 74546951503801 ()
  • 04546951503802 ()


  • Manual endodontic file/rasp, reusable

MANI MEDIUM H-FILES - 04546951503734

MANI H-FILES
MANI, INC.
21MM #27
In Commercial Distribution

  • 74546951503733 ()
  • 04546951503734 ()


  • Manual endodontic file/rasp, reusable

MANI MEDIUM K-FILES - 04546951502706

MANI K-FILES
MANI, INC.
25mm #27
In Commercial Distribution

  • 74546951502705 ()
  • 04546951502706 ()


  • Manual endodontic file/rasp, reusable

MANI MEDIUM K-FILES - 04546951502638

MANI K-FILES
MANI, INC.
21mm #27
In Commercial Distribution

  • 74546951502637 ()
  • 04546951502638 ()


  • Manual endodontic file/rasp, reusable
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