Duns Number:926684994
Device Description: HDi System Overpack p/n 800994-002Contents: System Console, Linear Translation System (LTS HDi System Overpack p/n 800994-002Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply
Catalog Number
-
Brand Name
ACIST HDi® HD IVUS System
Version/Model Number
017986
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
8429ba70-efe4-42c8-b27d-dcc8a681207e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 09, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 193 |