Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

74449A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

3806a16c-3e44-44cf-abbf-8ac5a19f12e8

Public Version Date

July 22, 2019

Public Version Number

3

DI Record Publish Date

August 20, 2016

Package DI Number

20809160020064

Quantity per Package

20

Contains DI Package

10809160020067

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-