Catalog Number

AE05ML

Brand Name

WECK

Version/Model Number

IPN010797

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

K152081,K152081,K152081

Product Code

FZP

Product Code Name

CLIP, IMPLANTABLE

Public Device Record Key

35a9bd19-fd47-4ee0-b881-5d166c013b3f

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

September 30, 2016

Package DI Number

24026704553123

Quantity per Package

3

Contains DI Package

04026704553129

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box