Duns Number:312576506
Device Description: LISS Solution; 2 x 100 mL bottle for Use with the IH-System
Catalog Number
-
Brand Name
IH-LISS Solution
Version/Model Number
813520100
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
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
KSG
Product Code Name
Media, Potentiating For In Vitro Diagnostic Use
Public Device Record Key
01dde623-b952-4bb2-a810-d6f466c9f192
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
April 05, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| U | Unclassified | 21 |