Catalog Number

-

Brand Name

Detachable endo pocket

Version/Model Number

FEP936116B

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

3c09c514-f605-4549-9cae-850baa311610

Public Version Date

February 17, 2020

Public Version Number

3

DI Record Publish Date

March 26, 2018

Package DI Number

24714127863065

Quantity per Package

10

Contains DI Package

14714127863068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton