Catalog Number

-

Brand Name

MedTronic

Version/Model Number

PKSDE001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 25, 2017

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

07dc606e-fc7d-4738-9c4e-79dcc2745b35

Public Version Date

July 22, 2019

Public Version Number

3

DI Record Publish Date

April 24, 2017

Package DI Number

20809160145705

Quantity per Package

20

Contains DI Package

10809160145708

Package Discontinue Date

September 25, 2017

Package Status

Not in Commercial Distribution

Package Type

-