Catalog Number

TBSC003-12

Brand Name

AVID TruCustom

Version/Model Number

TBSC003-12_0004

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LRO

Product Code Name

General surgery tray

Public Device Record Key

74200d1b-3908-4fad-bda1-8d4c2fc9e2fb

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 14, 2018

Package DI Number

20809160218676

Quantity per Package

3

Contains DI Package

10809160218679

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-