Catalog Number

NA

Brand Name

NA

Version/Model Number

TDL104

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

e0be6216-2ac2-4fe0-9134-3c1ba8e7078e

Public Version Date

November 15, 2018

Public Version Number

1

DI Record Publish Date

October 15, 2018

Package DI Number

20858965006131

Quantity per Package

10

Contains DI Package

00858965006137

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-