Duns Number:828682240
Device Description: ShuntCheck Test Pack consisting of a ShuntCheck Thermosensor, an Instant Cold Pack and a s ShuntCheck Test Pack consisting of a ShuntCheck Thermosensor, an Instant Cold Pack and a skin marker in a clamshell container
Catalog Number
TP-1
Brand Name
ShuntCheck Test Pack
Version/Model Number
TP-1
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
K123554,K123554
Product Code
JXG
Product Code Name
Shunt, Central Nervous System And Components
Public Device Record Key
a4e01a46-1994-4dd9-901b-31be87bf0ffc
Public Version Date
November 19, 2018
Public Version Number
1
DI Record Publish Date
October 18, 2018
Package DI Number
10865435000318
Quantity per Package
10
Contains DI Package
00865435000335
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |