Catalog Number

-

Brand Name

ACIST HDi® HD IVUS System

Version/Model Number

017986

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

-

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

OBJ

Product Code Name

Catheter, Ultrasound, Intravascular

Public Device Record Key

2b6fbed6-ac7c-4e54-b3ef-cb75e3d7831d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-