Catalog Number

523736

Brand Name

WECK

Version/Model Number

IPN008658

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

Product Code

FZP

Product Code Name

CLIP, IMPLANTABLE

Public Device Record Key

66c2ceaa-db41-4307-b75c-fa167ae764d6

Public Version Date

August 10, 2022

Public Version Number

5

DI Record Publish Date

August 16, 2018

Package DI Number

64026704600634

Quantity per Package

48

Contains DI Package

54026704600637

Package Discontinue Date

August 09, 2022

Package Status

Not in Commercial Distribution

Package Type

Box