Catalog Number

544200

Brand Name

WECK

Version/Model Number

IPN009033

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K133202,K133202,K133202

Product Code

FZP

Product Code Name

CLIP, IMPLANTABLE

Public Device Record Key

f5bcb96e-c1e5-4225-a77d-733cb6c350f7

Public Version Date

August 17, 2022

Public Version Number

5

DI Record Publish Date

October 16, 2015

Package DI Number

24026704601084

Quantity per Package

20

Contains DI Package

14026704601087

Package Discontinue Date

August 10, 2022

Package Status

Not in Commercial Distribution

Package Type

Box