Catalog Number

G3-R12HT

Brand Name

ENTRIPORT

Version/Model Number

G3-R12HT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 08, 2022

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

-

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

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

40eb4be6-c4f2-4001-99eb-d08d284b0214

Public Version Date

June 09, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-