PSL Portable Slit Lamp - Handheld, battery powered, biomicroscope that - REICHERT, INC.

Duns Number:126650253

Device Description: Handheld, battery powered, biomicroscope that projects light into a patient’s eye. It i Handheld, battery powered, biomicroscope that projects light into a patient’s eye. It is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosisof diseases or trauma which affect the structural properties of the anterior eye segment.

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More Product Details

Catalog Number

-

Brand Name

PSL Portable Slit Lamp

Version/Model Number

15090

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

K061330

Product Code Details

Product Code

HJO

Product Code Name

Biomicroscope, Slit-Lamp, Ac-Powered

Device Record Status

Public Device Record Key

2f4923c0-ab4a-44b1-b150-cc9ed8329534

Public Version Date

April 08, 2022

Public Version Number

4

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"REICHERT, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22