Catalog Number

-

Brand Name

ESPINER TISSUE RETRIEVAL SYSTEM

Version/Model Number

EMP160-INS

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

0e882495-65e3-4801-aa1a-c1660e1a4d60

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

5060358120442

Quantity per Package

5

Contains DI Package

05060358122040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX