Catalog Number

OSC-8F-15LT/C

Brand Name

One-Step™

Version/Model Number

00884450537343

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

GBX

Product Code Name

CATHETER, IRRIGATION

Public Device Record Key

34d026aa-cf94-47ec-a5f5-0a69524773b6

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

October 05, 2021

Package DI Number

20884450537347

Quantity per Package

22

Contains DI Package

10884450537340

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-