Catalog Number

523870

Brand Name

WECK

Version/Model Number

IPN028147

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"

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

K132658,K132658,K132658,K132658,K132658

Product Code

FZP

Product Code Name

CLIP, IMPLANTABLE

Public Device Record Key

6d535673-cfec-45af-acdd-ef7cbc4328d2

Public Version Date

August 31, 2022

Public Version Number

6

DI Record Publish Date

September 27, 2018

Package DI Number

54026704625005

Quantity per Package

12

Contains DI Package

44026704625008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case