ESSILOR RETINA 800 - Retina 800 is an automatic eye-fundus camera - ESSILOR INTERNATIONAL

Duns Number:277373213

Device Description: Retina 800 is an automatic eye-fundus camera intended for taking digital images of a human Retina 800 is an automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent

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More Product Details

Catalog Number

-

Brand Name

ESSILOR RETINA 800

Version/Model Number

RET1IN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K180306

Product Code Details

Product Code

HKI

Product Code Name

Camera, Ophthalmic, Ac-Powered

Device Record Status

Public Device Record Key

29ea0850-edcb-448d-b5f3-6ad70b110340

Public Version Date

April 10, 2020

Public Version Number

1

DI Record Publish Date

April 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ESSILOR INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 15