Catalog Number

530148

Brand Name

Design Options®

Version/Model Number

530148

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2019

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

3d7c7c07-2719-4f9b-9606-6a98c42ff22e

Public Version Date

June 15, 2020

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-