Catalog Number

-

Brand Name

BIG60™

Version/Model Number

00884450088746

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MAV

Product Code Name

Syringe, balloon inflation

Public Device Record Key

f93886a0-d7a6-481a-8787-ad22fec8e476

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

10884450088743

Quantity per Package

5

Contains DI Package

00884450088746

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-