Catalog Number

-

Brand Name

DemeLENE

Version/Model Number

PM259200,65A24

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

OCW

Product Code Name

Endoscopic Tissue Approximation Device

Public Device Record Key

c29db6aa-101c-47cc-806b-470e77ef3a33

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

November 28, 2017

Package DI Number

30652927256216

Quantity per Package

12

Contains DI Package

10652927256212

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-