Catalog Number

-

Brand Name

Encore™ 26 Advantage Kit

Version/Model Number

H74904527011

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)

Yes

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

f8c2c66f-63e3-41ea-b129-86f9d1f25dd7

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

08714729127048

Quantity per Package

5

Contains DI Package

08714729180005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-