Catalog Number

EK238SU

Brand Name

AESCULAP

Version/Model Number

EK238SU

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 17, 2021

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

c2538035-053b-4b48-a08d-4d3656a911fc

Public Version Date

January 19, 2022

Public Version Number

8

DI Record Publish Date

February 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-