Catalog Number

GBMC019-07

Brand Name

AVID TruCustom

Version/Model Number

GBMC019-07_0008

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

b2af9943-f837-4fcf-9d46-30bf4cfb99e4

Public Version Date

September 13, 2018

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

20809160007867

Quantity per Package

8

Contains DI Package

10809160007860

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-