Catalog Number

-

Brand Name

Angioway

Version/Model Number

LP-P-30S

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

PTM

Product Code Name

Syringe, Balloon Inflation, Exempt

Public Device Record Key

5759bea8-e33c-44e3-b5d5-a3d2deec6dfa

Public Version Date

May 06, 2020

Public Version Number

3

DI Record Publish Date

May 23, 2018

Package DI Number

16936733735890

Quantity per Package

5

Contains DI Package

06936733735893

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box