Catalog Number

506616H

Brand Name

RAIN Sheath Transradial

Version/Model Number

506616H

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

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

ada031a4-c8cd-4d38-bbf8-5c6477ff0475

Public Version Date

September 14, 2022

Public Version Number

7

DI Record Publish Date

October 09, 2018

Package DI Number

20705032078891

Quantity per Package

5

Contains DI Package

10705032078894

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX