Catalog Number

OSC-8F-7L/B

Brand Name

One-Step™

Version/Model Number

00884450298909

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

f9377d80-c11e-414d-82de-7c166cfed676

Public Version Date

December 05, 2019

Public Version Number

1

DI Record Publish Date

November 27, 2019

Package DI Number

20884450298903

Quantity per Package

22

Contains DI Package

10884450298906

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-