Catalog Number

G3-05-NB

Brand Name

ENTRIPORT

Version/Model Number

G3-05-NB

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"

-

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

K142464,K142464,K142464

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

5cf4e86f-aa26-4d9d-8b3e-40ac9075b8c9

Public Version Date

January 09, 2020

Public Version Number

4

DI Record Publish Date

October 17, 2017

Package DI Number

40653405081907

Quantity per Package

10

Contains DI Package

30653405081900

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX