Catalog Number

530173

Brand Name

Design Options®

Version/Model Number

530173

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 29, 2021

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

OFT

Product Code Name

Spinal epidural anesthesia kit

Public Device Record Key

f65ac524-eba0-4c68-8143-212ca4979811

Public Version Date

July 30, 2021

Public Version Number

6

DI Record Publish Date

February 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-