Catalog Number

GS-R6ST1C75W

Brand Name

R2P Destination Slender

Version/Model Number

GS-R6ST1C75W

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

504fb912-3efe-4418-b7af-78febdd2863d

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

April 10, 2020

Package DI Number

50389701012365

Quantity per Package

5

Contains DI Package

00389701012360

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton