Catalog Number

NA

Brand Name

NA

Version/Model Number

TDL112

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

2b469ea2-3dcc-4617-8c68-da7bddab781d

Public Version Date

November 12, 2018

Public Version Number

1

DI Record Publish Date

October 11, 2018

Package DI Number

20858965006216

Quantity per Package

10

Contains DI Package

00858965006212

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA