Catalog Number

ICM-000-0568

Brand Name

ESU Shroud

Version/Model Number

ICM-000-0568

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

a1ef8e66-0dc3-4843-9e4b-52e96c7bcf0a

Public Version Date

April 08, 2019

Public Version Number

1

DI Record Publish Date

March 29, 2019

Package DI Number

00817688022497

Quantity per Package

25

Contains DI Package

00817688022480

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-