Catalog Number

OSUM205

Brand Name

AVID TruCustom

Version/Model Number

OSUM205_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

OES

Product Code Name

Cardiac catheterization kit

Public Device Record Key

cde213ef-dd47-4c47-9aaa-e29d852af998

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 09, 2016

Package DI Number

20809160007829

Quantity per Package

50

Contains DI Package

10809160007822

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-