Catalog Number

001204

Brand Name

WECK

Version/Model Number

IPN002003

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

K982313,K982313,K982313,K982313

Product Code

FZP

Product Code Name

CLIP, IMPLANTABLE

Public Device Record Key

b84da274-e048-45c2-a7ea-57bc1c827849

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

October 20, 2017

Package DI Number

34026704410225

Quantity per Package

25

Contains DI Package

54026704410229

Package Discontinue Date

November 06, 2019

Package Status

Not in Commercial Distribution

Package Type

Box