Catalog Number

504155-28

Brand Name

Advance Dental Products

Version/Model Number

504155-28

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

DSP

Product Code Name

System, balloon, intra-aortic and control

Public Device Record Key

0e921d37-f6b8-440c-921e-9a1d635b236c

Public Version Date

August 03, 2021

Public Version Number

1

DI Record Publish Date

July 26, 2021

Package DI Number

20850002458644

Quantity per Package

10

Contains DI Package

10850002458647

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE