RetCam Portable - The RetCam Portable Ophthalmic Imaging System is - CLARITY MEDICAL SYSTEMS, INC.

Duns Number:808456037

Device Description: The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capt The RetCam Portable Ophthalmic Imaging System is designed to allow the quick and easy capture of wide field, high resolution, fully digital images and videos of the eye.

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More Product Details

Catalog Number

-

Brand Name

RetCam Portable

Version/Model Number

RetCam Portable

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 31, 2017

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HKI

Product Code Name

Camera, Ophthalmic, Ac-Powered

Device Record Status

Public Device Record Key

078d30bc-b317-4988-b8e2-3de82e1623ef

Public Version Date

February 09, 2021

Public Version Number

3

DI Record Publish Date

December 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLARITY MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3