Catalog Number

EFX001

Brand Name

WECK

Version/Model Number

IPN002709

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"

Yes

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

K103412,K103412,K103412

Product Code

OCW

Product Code Name

Endoscopic tissue approximation device

Public Device Record Key

add87a6f-4337-4352-9542-beab24e7474f

Public Version Date

April 28, 2022

Public Version Number

11

DI Record Publish Date

October 30, 2016

Package DI Number

24026704558838

Quantity per Package

5

Contains DI Package

04026704558834

Package Discontinue Date

April 26, 2022

Package Status

Not in Commercial Distribution

Package Type

Multipack