Catalog Number

002204

Brand Name

WECK

Version/Model Number

IPN914926

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"

-

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

00f7289f-22fe-4474-bda6-e2c59cc09418

Public Version Date

June 21, 2022

Public Version Number

5

DI Record Publish Date

January 11, 2021

Package DI Number

44026704696312

Quantity per Package

6

Contains DI Package

24026704696318

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case