Catalog Number

-

Brand Name

Endoplus

Version/Model Number

E364SLR-45

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

-

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

K925079

Product Code

HET

Product Code Name

Laparoscope, Gynecologic (And Accessories)

Public Device Record Key

aafab9c8-1f13-47dc-a277-fa846cd39058

Public Version Date

August 21, 2019

Public Version Number

2

DI Record Publish Date

December 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-