Catalog Number

528236

Brand Name

WECK

Version/Model Number

IPN028494

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"

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

-

Product Code

GDT

Product Code Name

STAPLE, REMOVABLE (SKIN)

Public Device Record Key

8ea8a1eb-28dc-486d-9cce-d4271f97b385

Public Version Date

March 10, 2021

Public Version Number

4

DI Record Publish Date

April 11, 2019

Package DI Number

44026704631795

Quantity per Package

10

Contains DI Package

34026704631798

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case