Catalog Number

570301

Brand Name

Design Options®

Version/Model Number

570301

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 21, 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

OGJ

Product Code Name

Nerve block tray

Public Device Record Key

1afc12e2-42e7-4c41-a5d6-34b2bb8c57c9

Public Version Date

December 27, 2021

Public Version Number

4

DI Record Publish Date

June 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-