Catalog Number

-

Brand Name

NA

Version/Model Number

TBL134

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

OFU

Product Code Name

Spinal Anesthesia Kit

Public Device Record Key

f6cf2f4a-224c-4132-bef9-bbeb35c0063c

Public Version Date

July 22, 2019

Public Version Number

2

DI Record Publish Date

May 03, 2019

Package DI Number

20858965006445

Quantity per Package

10

Contains DI Package

00858965006441

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-