Catalog Number

SSESHR04

Brand Name

STERIS

Version/Model Number

SSESHR04

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

eb04b477-7ded-4081-aed7-f30809a68a7f

Public Version Date

October 27, 2021

Public Version Number

1

DI Record Publish Date

October 19, 2021

Package DI Number

00817688023609

Quantity per Package

25

Contains DI Package

00817688023593

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-