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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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Welch Allyn, Inc. - 00732094323948

RV700 IMAGER SET TRADE-UP DISTRIBUTOR
WELCH ALLYN, INC.
901124
Not in Commercial Distribution

  • 00732094323948 ()
RV700TUD-B

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094299939

RETINAVUE700 IMAGER US
WELCH ALLYN, INC.
901124
Not in Commercial Distribution

  • 00732094299939 ()
  • 00732094323214 ()
RV700 B

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094252835

RETINAVUE100 IMAGER PRO SET US PLUG
WELCH ALLYN, INC.
901103
In Commercial Distribution

  • 00732094252835 ()
RV100PRO-B

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094258851

RETINAVUE700 IMAGER SET US PLUG
WELCH ALLYN, INC.
901124
Not in Commercial Distribution

  • 00732094258851 ()
RV700-B

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094225938

Welch Allyn Handheld RetinaVue 100 Imager with Charging Dock, Reusable Eye Cup, USB Cable, and 1 Year Partners in Care Comprehensive Program; Lithium-Ion 3.6V Battery. Note: Diagnostic interpretation services are a necessary component of the RetinaVue solution and are contracted directly with RetinaVue P.C.
WELCH ALLYN, INC.
901103
In Commercial Distribution

  • 00732094225938 ()
RV100-B

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094223873

Topcon TRC-NW400 Non-Mydriatic Retinal Desktop Camera, use with RetinaVue Network. Note: Diagnostic interpretation services are a necessary component of the RetinaVue solution and are contracted directly with RetinaVue P.C.
WELCH ALLYN, INC.
901103
Not in Commercial Distribution

  • 00732094223873 ()
723427

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094214758

RETeval-DR Disp. Sensor Strips 50-Pair
WELCH ALLYN, INC.
901102
In Commercial Distribution

  • 00732094214758 ()
RETEVAL-SS-50

  • Ophthalmic fundus camera

Welch Allyn, Inc. - 00732094214741

Welch Allyn RETeval-DR Electroretinograph including Disposable Sensor Strips (2 Packs of 50 ea), Charging Dock, and USB Cable; Lithium-Ion Battery (#RETeval-ACC-02); 100-240 V, 50-60 Hz, IEC Plug Types A, G, E/F, and I; Multiple Languages
WELCH ALLYN, INC.
901101
In Commercial Distribution

  • 00732094214741 ()
RETEVAL-001

  • Ophthalmic fundus camera

Signal set - 06430046260856

Signal product set including Signal Camera.
Optomed Oy
60101599A
In Commercial Distribution

  • 06430046260856 ()


  • Ophthalmic fundus camera

Signal Camera - 06430046260832

Ophthalmic fundus camera
Optomed Oy
41001595
In Commercial Distribution

  • 06430046260832 ()


  • Ophthalmic fundus camera

Visuscout 100 set FN - 06430046260634

Visuscout 100 set
Optomed Oy
60100054A
In Commercial Distribution

  • 06430046260634 ()


  • Ophthalmic fundus camera

ATOMLAB - 00718175000137

Thyroid Uptake System, Well Counter
BIODEX MEDICAL SYSTEMS, INC.
187-602
In Commercial Distribution

  • 00718175000137 ()
187-602

  • Thyroid-uptake nuclear medicine system

ATOMLAB - 00718175000021

Thyroid Uptake System, AtomLab 960, 230 VAC
BIODEX MEDICAL SYSTEMS, INC.
187-601
In Commercial Distribution

  • 00718175000021 ()
187-601

  • Thyroid-uptake nuclear medicine system

ATOMLAB - 00718175000014

Thyroid Uptake System, AtomLab 960, 120 VAC
BIODEX MEDICAL SYSTEMS, INC.
187-600
In Commercial Distribution

  • 00718175000014 ()
187-600

  • Thyroid-uptake nuclear medicine system

Vivicon - 00858848006445

Ophthalmic Camera
OPTOVUE, INC.
Vivicon
In Commercial Distribution

  • 00858848006445 ()
700-53597-001

  • Ophthalmic fundus camera

iCam - 00858848006414

iCam Camera Head 5MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006414 ()
700-49517-004

  • Ophthalmic fundus camera

iCam - 00858848006339

iCam Camera Head 5 MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006339 ()
700-49517-003

  • Ophthalmic fundus camera

iCam - 00858848006322

iCam Camera Head 5 MP
OPTOVUE, INC.
iCam100
In Commercial Distribution

  • 00858848006322 ()
700-49517-002

  • Ophthalmic fundus camera

Spect Ophthalmic Camera - 00853501008002

The Spect Ophthalmic Camera is a product consisting of an Apple iPhone, a mobile application (app), and an optical lens attachment and illumination source. The mobile app is accessible to users via the Apple App Store (Apple Inc.) for use on Spect issued iPhone devices. The Spect Ophthalmic Camera consists of a mechanical adaptor with a telescopic feature that houses a high-quality glass fundoscopic lens, and a white-light LED illumination source.
Spect Inc.
BOM001
In Commercial Distribution

  • 00853501008002 ()


  • Ophthalmic fundus camera

Natus - 00382830016896

RetCam Envision without FA
XLTEK
61-000400
In Commercial Distribution

  • 00382830016896 ()


  • Ophthalmic fundus camera
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