Slit Lamp HS-5500 - -. Magnfication : 5 position rotation drum -. - Huvitz Co., Ltd.

Duns Number:688154202

Device Description: -. Magnfication : 5 position rotation drum -. Lamp : LED Lamp ( 10V 4.4W)

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More Product Details

Catalog Number

HS-5500(LED)

Brand Name

Slit Lamp HS-5500

Version/Model Number

HS-5500(LED)

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

K093639

Product Code Details

Product Code

HJO

Product Code Name

Biomicroscope, Slit-Lamp, Ac-Powered

Device Record Status

Public Device Record Key

39e26533-cb97-4de5-b2c4-49c9bcf9bc4c

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

May 09, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HUVITZ CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 15