Catalog Number

-

Brand Name

ESPINER TISSUE RETRIEVAL SYSTEM

Version/Model Number

EMP80ECO-R

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

K111845,K111845

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

f02f962b-45c5-42fa-afd6-3e1eab94e0bc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 24, 2017

Package DI Number

05060358122293

Quantity per Package

10

Contains DI Package

05060358122279

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX