Catalog Number

-

Brand Name

AVID TruCustom

Version/Model Number

BRYN027-01_0007

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

HFW

Product Code Name

Clamp, umbilical

Public Device Record Key

8ece7f42-6ff7-48ab-930f-dcdfb9a68625

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 09, 2016

Package DI Number

20809160030148

Quantity per Package

100

Contains DI Package

10809160030141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-