Catalog Number

-

Brand Name

NA

Version/Model Number

TDL110

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

OGD

Product Code Name

Custom Anesthesia Tray

Public Device Record Key

73a43d0a-41b4-4e26-a835-d07e88570125

Public Version Date

October 01, 2018

Public Version Number

1

DI Record Publish Date

August 30, 2018

Package DI Number

20858965006193

Quantity per Package

10

Contains DI Package

00858965006199

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-