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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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VuPad Ophthalmic Ultrasound System - 00896100002019

The VuPad AP Ophthalmic Ultrasound System is a portable, ultrasound biometric ruler that is a non-invasive, active device intended for imaging ocular features for diagnostic purposes and measuring central corneal thickness. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The VuPad A-Scan is used by coupling the probe/transducer to the eye either through direct contact or by immersion method with scan mode capabilities for cataract, dense cataract, aphakic, and pseudophakic. The VuPad AP system is a stand alone system that runs on a Windows 10 platform and includes the portable A-Scan tablet, a 10 MHz A-probe, 20 MHz pachymetry probe, foot switch and operator manual.
SONOMED, INC.
VuPad AP
In Commercial Distribution

  • 00896100002019 ()
AP.580

  • Ophthalmic ultrasound imaging system

AXIALIS - 03700542625941

The AXIALIS Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. • Measurement of corneal thickness by ultrasonic means.
QUANTEL MEDICAL
AXIALIS
In Commercial Distribution

  • 03700542625941 ()


  • Ophthalmic ultrasound imaging system

COMPACT TOUCH - 03700542625545

Ophthalmic Ultrasound System: A/B Scan and Pachymetry The QUANTEL MEDICAL COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Visualization of the interior of the eye and the orbit by A and B scans. • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. • Measurement of corneal thickness by ultrasonic means.
QUANTEL MEDICAL
COMPACT TOUCH 2017
In Commercial Distribution

  • 03700542625545 ()


  • Ophthalmic ultrasound imaging system

ABSOLU - 03700542625521

The ABSolu is a high definition multifunction ophthalmic ultrasound system used for: - Axial Length measurement of the eye by ultrasonic means; - Implanted IOL power calculation, using the axial length measurement; - Visualization of the interior of the eye and the orbit by A and B scans. - ABSOLU S only: Advanced diagnostic - Standardized echography provides detailed information about the internal reflectivity of tissues and allows optimal tissues differentiation, localization and measurement of structures in the eye and orbit.
QUANTEL MEDICAL
ABSOLU
In Commercial Distribution

  • 03700542625521 ()


  • Ophthalmic ultrasound imaging system

AXIS NANO - 03700542625033

Ophthalmic Ultrasound Biometer: Biometry and IOL Calculation The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including: • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement.
QUANTEL MEDICAL
AXIS NANO
In Commercial Distribution

  • 03700542625033 ()


  • Ophthalmic ultrasound imaging system

COMPACT TOUCH STS - 03700542625026

Ophthalmic Ultrasound Biomicroscope UBM and automatic STS measurement for ICL sizing The QUANTEL MEDICAL Compact Touch STS UBMTM Ophthalmic Ultrasound System (and its associated Linear 50 MHz probe) is intended to be used for diagnostic imaging and measurement of the eye including: • Visualization of the interior of the eye by B scans. • Make measurements inside the eye (Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber depth).
QUANTEL MEDICAL
COMPACT TOUCH STS UBM
In Commercial Distribution

  • 03700542625026 ()


  • Ophthalmic ultrasound imaging system

COMPACT TOUCH - 03700542625019

Ophthalmic Ultrasound System: A/B Scan and Pachymetry The QUANTEL MEDICAL COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Visualization of the interior of the eye and the orbit by A and B scans. • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. • Measurement of corneal thickness by ultrasonic means.
QUANTEL MEDICAL
COMPACT TOUCH
In Commercial Distribution

  • 03700542625019 ()


  • Ophthalmic ultrasound imaging system

AVISO (S) - 03700542625002

AVISO (S) Ophthalmic A (A-Std), B Scan and UBM Ultrasound System The QUANTEL MEDICAL AVISO modular platform is an ultrasound system intended to be used for: • Axial Length measurement of the eye by ultrasonic means • Implanted IOL power calculation, using the Axial Length measurement • Visualization of the interior of the eye and the orbit by A and B scans (• Advanced diagnostic: standardized echography provides detailed information about the internal reflectivity of tissues and allows optimal tissues differentiation, localization and measurement of structures in the eye and orbit.)
QUANTEL MEDICAL
AVISO (S)
In Commercial Distribution

  • 03700542625002 ()


  • Ophthalmic ultrasound imaging system

Ultrasound Biomicroscope - 06948941132005

MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes.
Meda Co., Ltd
MD-320W
In Commercial Distribution

  • 06948941132005 ()


  • Ophthalmic ultrasound imaging system

Ultrasonic Biometer for Ophthalmology - 06948941111109

MD-1000A Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of biometric parameters.
Meda Co., Ltd
MD-1000A
In Commercial Distribution

  • 06948941111109 ()


  • Ophthalmic ultrasound imaging system

Ultrasonic A/B Scanner for Ophthalmology - 06948941102237

MD-2300S Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement.
Meda Co., Ltd
MD-2300S
In Commercial Distribution

  • 06948941102237 ()


  • Ophthalmic ultrasound imaging system

Ultrasonic A/B Scanner for Ophthalmology - 06948941102220

ODM-2200 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement.
Meda Co., Ltd
ODM-2200
In Commercial Distribution

  • 06948941102220 ()


  • Ophthalmic ultrasound imaging system

Ultrasonic A/B Scanner for Ophthalmology - 06948941102213

ODM-2100 Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement.
Meda Co., Ltd
ODM-2100
In Commercial Distribution

  • 06948941102213 ()


  • Ophthalmic ultrasound imaging system

Ophthalmic Ultrasound Examination Instrument - 06973211070756

No Description
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-2000P
In Commercial Distribution

  • 06973211070756 ()


  • Ophthalmic ultrasound imaging system

Ophthalmic Ultrasound Examination Instrument - 06973211070749

No Description
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-2000A
In Commercial Distribution

  • 06973211070749 ()


  • Ophthalmic ultrasound imaging system

Ophthalmic Ultrasound Examination Instrument - 06973211070718

No Description
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-3000C
In Commercial Distribution

  • 06973211070718 ()


  • Ophthalmic ultrasound imaging system

Ophthalmic Ultrasound Examination Instrument - 06973211070701

No Description
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-3000B
In Commercial Distribution

  • 06973211070701 ()


  • Ophthalmic ultrasound imaging system

Ophthalmic Ultrasound Examination Instrument - 06973211070640

No Description
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-2000AP
In Commercial Distribution

  • 06973211070640 ()


  • Ophthalmic ultrasound imaging system

Ophthalmic Ultrasound Examination Instrument - 06973211070633

No Description
CHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTD
SK-3000A
In Commercial Distribution

  • 06973211070633 ()


  • Ophthalmic ultrasound imaging system

ArcScan Insight 100 - B017ED102

No Description
ARCSCAN, INC.
EyeSeal Disposable
In Commercial Distribution

  • B017ED113 ()
  • B017ED102 ()
ED1

  • Ophthalmic ultrasound imaging system

ArcScan Insight 100 - B017AS100

No Description
ARCSCAN, INC.
AS100
In Commercial Distribution

  • B017AS100 ()
AS100-120

  • Ophthalmic ultrasound imaging system

BioPlex 2200 - 00847865012607

EBV IgG Assay Protocol File CD, SW4.1_v1, US
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865012607 ()

  • 1 Each
6651270D

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865011006

Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
Not in Commercial Distribution

  • 00847865011006 ()

  • 1 Each
6653870D

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865010986

BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865010986 ()

  • 1 Each
6653270E

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex

BioPlex 2200 - 00847865002240

ToRC IgG Assay Protocol File CD, SW 4_v3
BIO-RAD LABORATORIES, INC.
SW4_V3
In Commercial Distribution

  • 00847865002240 ()

  • 1 Each
6651670G

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Medline Industries, Inc. - 10888277842151

FCP BIPOLAR 7 1.5 BAY CT CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR10A
In Commercial Distribution

  • 10888277842151 ()
  • 40888277842152 ()
DYNJBIPLR10A

  • General surgical procedure kit, non-medicated, reusable

MONO STAN RF FORCEPS - 00841494104009

MONO STAN RF FORCEPS W CABLE & VIDEO CD
Cynosure, LLC
MJ11
In Commercial Distribution

  • 00841494104009 ()
MJ11

  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

ARCHITECT - 00380740152130

ARCHITECT cSystem Conv Units e-Assay CD ROM V15.0
ABBOTT LABORATORIES
8G98-18
In Commercial Distribution

  • 00380740152130 ()
08G9818

  • Laboratory instrument/analyser application software IVD

ARCHITECT - 00380740152147

ARCHITECT cSystem SI Units e-Assay CD ROM V15.0
ABBOTT LABORATORIES
4J62-18
In Commercial Distribution

  • 00380740152147 ()
04J6218

  • Laboratory instrument/analyser application software IVD

iQ®200 - 10837461002475

iQ®200 Body Fluids Module (CD only)
BECKMAN COULTER IRELAND INC.
Body Fluids Module
In Commercial Distribution

  • 10837461002475 ()
800-3704

  • Laboratory instrument/analyser application software IVD

BioPlex - 03610522207992

BPX Syph Total& RPR Mnl&CD SW4.3 v5
BIO-RAD LABORATORIES, INC.
SW4.3 v5.0
In Commercial Distribution

  • 03610522207992 ()

  • 1 Each
12014549

  • Treponema pallidum total antibody IVD, kit, fluorescent immunoassay

SCHICK - D764B63060001

USBCAM4 KIT (CAMERA; HOLDER; 25 SHEATHS; DRIVER CD)
SIRONA DENTAL, INC.
B6306000
In Commercial Distribution

  • D764B63060001 ()


  • Diagnostic-imaging photographic film, self-developing

SCHICK - D764B63030001

USBCAM KIT (CAMERA; HOLDER; 25 SHEATHS; DRIVER CD)
SIRONA DENTAL, INC.
B6303000
In Commercial Distribution

  • D764B63030001 ()


  • Diagnostic-imaging photographic film, self-developing

BOSS Instruments - 00888515228634

Sickle Knife, 7.5mm cd bld, 6 1/2"
BOSS INSTRUMENTS, LTD., INC.
90-3301
In Commercial Distribution

  • 00888515228634 ()
90-3301

  • Ear knife

ELBOW FIXATOR - 18032568030778

CD UNIT SPACERS (1 PAIR) FOR ELBOW FIXATOR
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568030778 ()
10076

  • External orthopaedic fixation system, reusable

Boss Babe Body Tampons - 07290016625547

Boss Babe Body Bulk Tampons - 500 CD Super
AL-BAD MASSUOT YITZHAK LTD
BBUSBK500
In Commercial Distribution

  • 07290016625547 ()
  • 07290016625196 ()

  • Absorbency


  • Menstrual tampon, unscented

Boss Babe Body Tampons - 07290016625530

Boss Babe Body Bulk Tampons - 500 CD Regular
AL-BAD MASSUOT YITZHAK LTD
BBURBK500
In Commercial Distribution

  • 07290016625530 ()
  • 07290016625189 ()

  • Absorbency


  • Menstrual tampon, unscented

ADVANCED LIMB RECONSTRUCTION SYSTEM - 18033509855665

ADV GARCHES CD UNIT STANDARD EXTENDS 5,5 CM
ORTHOFIX SRL
1
In Commercial Distribution

  • 18033509855665 ()

  • Width: 116 Millimeter
53004

  • External orthopaedic fixation system, reusable

ADULT LIMB RECONSTRUCTION SYSTEM - 18032568036404

CD UNIT FOR MICROMETRIC SWIVELLING CLAMP FOR LRS
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568036404 ()
50112

  • External orthopaedic fixation system, reusable

DETECTABUSE - 00810042684447

STABILITY/QC CONTROL MENU CD, Cutoff 150%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008793
In Commercial Distribution

  • 00810042684447 ()
18008793

  • Multiple drugs of abuse IVD, control
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