Catalog Number

-

Brand Name

N/A

Version/Model Number

TBL213

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"

-

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

b11d8705-4660-4a90-ac0f-df4a41d22dad

Public Version Date

May 14, 2021

Public Version Number

1

DI Record Publish Date

May 06, 2021

Package DI Number

20858965006643

Quantity per Package

10

Contains DI Package

00858965006649

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-