Catalog Number

-

Brand Name

Classic Sheath™

Version/Model Number

00884450163894

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

4f0659f9-97f2-4188-9a90-de9ef7e37620

Public Version Date

November 01, 2021

Public Version Number

7

DI Record Publish Date

October 12, 2016

Package DI Number

10884450163891

Quantity per Package

5

Contains DI Package

00884450163894

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-