Catalog Number

-

Brand Name

N/A

Version/Model Number

TDLU212

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

OGJ

Product Code Name

Nerve Block Tray

Public Device Record Key

2e492f9c-fe75-4bc7-8656-7ce0523a996a

Public Version Date

May 19, 2021

Public Version Number

1

DI Record Publish Date

May 11, 2021

Package DI Number

20858965006674

Quantity per Package

10

Contains DI Package

00858965006670

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-