Catalog Number

CSGWORBC19M

Brand Name

SafeSheath CSG

Version/Model Number

00884450484418

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

e912f75b-cb47-4ce3-8e06-e8e4610cbd1b

Public Version Date

November 01, 2021

Public Version Number

3

DI Record Publish Date

November 13, 2020

Package DI Number

10884450484415

Quantity per Package

5

Contains DI Package

00884450484418

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-