Catalog Number

-

Brand Name

ENDOEYE FLEX LENS CLEANING SHEATH FOR 10MM

Version/Model Number

OLYMPUS LC-S190-10-F

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 12, 2022

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

Yes

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

-

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

534b3f8f-8a61-44f6-aba6-86d381921055

Public Version Date

August 15, 2022

Public Version Number

8

DI Record Publish Date

September 21, 2016

Package DI Number

04953170353222

Quantity per Package

5

Contains DI Package

04953170353239

Package Discontinue Date

August 12, 2022

Package Status

Not in Commercial Distribution

Package Type

-