Catalog Number

LS7347150O

Brand Name

iLESSYS®

Version/Model Number

LS7347150O

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K051827

Product Code

HRX

Product Code Name

Arthroscope

Public Device Record Key

5eac733e-1cd3-4145-9288-95e475745891

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-