Catalog Number

-

Brand Name

ESU Shroud

Version/Model Number

ICM-000-0226

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"

Yes

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

3c4254fe-2703-420d-8e9e-2616fc1d27f0

Public Version Date

April 08, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

00817688021162

Quantity per Package

100

Contains DI Package

00817688021155

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-