Catalog Number

534737

Brand Name

WECK

Version/Model Number

IPN008947

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

79941043-1b00-4179-8c00-400a69fc181d

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

October 16, 2015

Package DI Number

24026704600841

Quantity per Package

12

Contains DI Package

14026704600844

Package Discontinue Date

October 18, 2017

Package Status

Not in Commercial Distribution

Package Type

Box