Catalog Number

-

Brand Name

NA

Version/Model Number

TDLS205

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

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OGE

Product Code Name

Epidural Anesthesia Kit

Public Device Record Key

6a224c74-f0af-4df8-9a65-d8ec4e688c48

Public Version Date

January 06, 2021

Public Version Number

1

DI Record Publish Date

December 29, 2020

Package DI Number

20858965006599

Quantity per Package

10

Contains DI Package

00858965006595

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-