Catalog Number

-

Brand Name

Cadwell Subdermal Corkscrew

Version/Model Number

302358-000

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

GXZ

Product Code Name

ELECTRODE, NEEDLE

Public Device Record Key

9be48c08-62b6-40cd-8400-c714897210d7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 05, 2016

Package DI Number

10840067101497

Quantity per Package

24

Contains DI Package

00840067101490

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box