LUMENIS - COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL

Duns Number:432448470

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More Product Details

Catalog Number

100272A50.L V31

Brand Name

LUMENIS

Version/Model Number

SL 9800 5X

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

K992836

Product Code Details

Product Code

HJO

Product Code Name

Biomicroscope, Slit-Lamp, Ac-Powered

Device Record Status

Public Device Record Key

a2910876-4c9f-4f67-8915-98ec3ec1227d

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

December 10, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 37