Duns Number:926684994
Device Description: HDi System Overpack, with ACIST Connect, JAPAN p/n 801081-001Contents: System Console, Lin HDi System Overpack, with ACIST Connect, JAPAN p/n 801081-001Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply, ACI Hardware
Catalog Number
-
Brand Name
ACIST HDi® HD IVUS System
Version/Model Number
016323
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
K173063
Product Code
OBJ
Product Code Name
Catheter, Ultrasound, Intravascular
Public Device Record Key
57e6c363-46e5-4763-b94a-a46068b53a87
Public Version Date
December 31, 2018
Public Version Number
1
DI Record Publish Date
November 30, 2018
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 |