Catalog Number

552157

Brand Name

Design Options®

Version/Model Number

552157

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 10, 2022

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OGE

Product Code Name

Epidural anesthesia kit

Public Device Record Key

88baf957-6ef5-44a3-a970-a16e98bad193

Public Version Date

March 14, 2022

Public Version Number

5

DI Record Publish Date

November 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-