ENDOEYE RIGID LENS CLEANING SHEATH FOR 10MM 30DEGREES - OLYMPUS MEDICAL SYSTEMS CORP.

Duns Number:711789789

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More Product Details

Catalog Number

-

Brand Name

ENDOEYE RIGID LENS CLEANING SHEATH FOR 10MM 30DEGREES

Version/Model Number

OLYMPUS LC-S190-10-30

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 2022

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

da55f729-c521-40ca-ae9b-01a0542ec859

Public Version Date

August 22, 2022

Public Version Number

5

DI Record Publish Date

March 31, 2017

Additional Identifiers

Package DI Number

04953170366895

Quantity per Package

5

Contains DI Package

04953170366901

Package Discontinue Date

August 19, 2022

Package Status

Not in Commercial Distribution

Package Type

-

"OLYMPUS MEDICAL SYSTEMS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 117
2 A medical device with a moderate to high risk that requires special controls. 1962
U Unclassified 52