Catalog Number

658505

Brand Name

WECK

Version/Model Number

IPN009317

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

-

Product Code

HBO

Product Code Name

CLIP, SCALP

Public Device Record Key

4db4a635-7930-4a33-9aa0-b90e733fa4cf

Public Version Date

September 02, 2019

Public Version Number

4

DI Record Publish Date

September 18, 2016

Package DI Number

24026704418347

Quantity per Package

10

Contains DI Package

04026704418343

Package Discontinue Date

August 30, 2019

Package Status

Not in Commercial Distribution

Package Type

Pouch