Duns Number:929856680
Device Description: Gastrointestinal sensor for use with the T-Stat monitor to measure ischemia in colorectal Gastrointestinal sensor for use with the T-Stat monitor to measure ischemia in colorectal tissue.
Catalog Number
-
Brand Name
Spectros T-Stat
Version/Model Number
CHT-060-REC 5mm
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
K081233,K081233
Product Code
MUD
Product Code Name
Oximeter, Tissue Saturation
Public Device Record Key
1a69dad9-5f39-4884-a9bf-069a66de8d23
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 17, 2016
Package DI Number
10851136007039
Quantity per Package
5
Contains DI Package
00851136007032
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. | 6 |