Catalog Number

BTDS003

Brand Name

AVID TruCustom

Version/Model Number

BTDS003_0005

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

LRO

Product Code Name

General surgery tray

Public Device Record Key

47df65e1-60c8-44ac-ae1c-6fb8e823e4d5

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

November 27, 2017

Package DI Number

20809160170981

Quantity per Package

20

Contains DI Package

10809160170984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-