Catalog Number

-

Brand Name

ACIST HDi® Linear Translation System (LTS)

Version/Model Number

017988

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 17, 2017

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

48ca8b20-b4e3-4584-b538-75bf1d168cd3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 09, 2016

Package DI Number

30841716101169

Quantity per Package

1

Contains DI Package

10841716101165

Package Discontinue Date

August 17, 2017

Package Status

Not in Commercial Distribution

Package Type

Shelf Box