Catalog Number

MIHS005-07

Brand Name

AVID TruCustom

Version/Model Number

MIHS005-07_0003

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

f311e608-b27c-4ac7-ae67-f41a5e2da502

Public Version Date

May 06, 2019

Public Version Number

1

DI Record Publish Date

April 26, 2019

Package DI Number

20809160236991

Quantity per Package

5

Contains DI Package

10809160236994

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-