Catalog Number

-

Brand Name

AVID TruCustom

Version/Model Number

AVID 8001_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

K020304,K020304

Product Code

FTA

Product Code Name

Light, surgical, accessories

Public Device Record Key

2c9bbfd8-b791-40f3-97b2-4502c80ed1a4

Public Version Date

November 22, 2018

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

20809160033996

Quantity per Package

100

Contains DI Package

10809160033999

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-