ESSILOR SL350H - Slit lamp microscopes are used to observe the - ESSILOR INTERNATIONAL

Duns Number:277373213

Device Description: Slit lamp microscopes are used to observe the disease of the anterior structures and tissu Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes

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More Product Details

Catalog Number

-

Brand Name

ESSILOR SL350H

Version/Model Number

SL350H

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

-

Product Code Details

Product Code

HJO

Product Code Name

Biomicroscope, Slit-Lamp, Ac-Powered

Device Record Status

Public Device Record Key

e73e963d-68e5-4177-bf45-de6b04ea0adb

Public Version Date

April 08, 2022

Public Version Number

3

DI Record Publish Date

September 23, 2016

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