Catalog Number

GBMC031-06

Brand Name

AVID TruCustom

Version/Model Number

GBMC031-06_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

LRO

Product Code Name

General surgery tray

Public Device Record Key

4624b1de-4e8f-4742-a16f-7d37f2a1531f

Public Version Date

September 13, 2018

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

20809160009960

Quantity per Package

20

Contains DI Package

10809160009963

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-