Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

78389

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 12, 2020

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

OFT

Product Code Name

Spinal epidural anesthesia kit

Public Device Record Key

bc101fa5-cd63-45ff-8847-d270a17c1556

Public Version Date

February 13, 2020

Public Version Number

3

DI Record Publish Date

July 30, 2018

Package DI Number

20809160202347

Quantity per Package

20

Contains DI Package

10809160202340

Package Discontinue Date

February 12, 2020

Package Status

Not in Commercial Distribution

Package Type

-