Xcel® 255 Slit Lamp - AC powered biomicroscope that projects light into - REICHERT, INC.

Duns Number:126650253

Device Description: AC powered biomicroscope that projects light into a patient's eye. The device is intende AC powered biomicroscope that projects light into a patient's eye. The device is intended for use in examining the anterior segment of the eye, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye.

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More Product Details

Catalog Number

-

Brand Name

Xcel® 255 Slit Lamp

Version/Model Number

15120

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

K063750

Product Code Details

Product Code

HJO

Product Code Name

Biomicroscope, Slit-Lamp, Ac-Powered

Device Record Status

Public Device Record Key

7eb252a9-9c74-4c98-9006-bb56aec2f999

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