MediWorks - AC-powered slit lamp biomicroscopes intended for - SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.

Duns Number:527884077

Device Description: AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior ey AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. They are used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

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More Product Details

Catalog Number

-

Brand Name

MediWorks

Version/Model Number

S280S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K100439

Product Code Details

Product Code

HJO

Product Code Name

Biomicroscope, Slit-Lamp, Ac-Powered

Device Record Status

Public Device Record Key

d946567e-2e16-4ec6-8f69-6dfc46c85914

Public Version Date

April 08, 2022

Public Version Number

6

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 33