Catalog Number

534737

Brand Name

WECK

Version/Model Number

IPN915136

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

K132658,K132658,K132658,K132658

Product Code

FZP

Product Code Name

CLIP, IMPLANTABLE

Public Device Record Key

aa2d6667-7aaf-4ee2-b0e0-a521e4bb2232

Public Version Date

August 18, 2021

Public Version Number

3

DI Record Publish Date

January 11, 2021

Package DI Number

44026704696268

Quantity per Package

12

Contains DI Package

34026704696261

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case