Catalog Number

-

Brand Name

ESPINER TISSUE RETRIEVAL SYSTEM

Version/Model Number

EMP200ECO-US

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 08, 2019

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

K111845,K111845

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

aa3f8df6-9613-4513-b293-52f2efaa9c3c

Public Version Date

July 09, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

5060358121524

Quantity per Package

5

Contains DI Package

05060358121937

Package Discontinue Date

July 08, 2019

Package Status

Not in Commercial Distribution

Package Type

BOX