Catalog Number

-

Brand Name

Endoplus

Version/Model Number

E347M-25

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

K925114

Product Code

HFI

Product Code Name

Coagulator, Culdoscopic (And Accessories)

Public Device Record Key

24dd6891-4c77-4875-b2f7-e1dab8b6a2d2

Public Version Date

July 18, 2022

Public Version Number

1

DI Record Publish Date

July 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-