Catalog Number

-

Brand Name

AVID TruCustom

Version/Model Number

DTOM001_0006

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

1c7d59da-dcee-49e5-b03b-397e69d704a0

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

September 29, 2017

Package DI Number

20809160164249

Quantity per Package

10

Contains DI Package

10809160164242

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-