Duns Number:058614483
Device Description: Room Scanner For use with the Situate Detection Console 200X
Catalog Number
01-0046
Brand Name
Situate
Version/Model Number
01-0046
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
-
Product Code
LWH
Product Code Name
Counter, sponge, surgical
Public Device Record Key
ea0943f3-a999-434c-92c6-a3add620054e
Public Version Date
November 27, 2019
Public Version Number
2
DI Record Publish Date
October 13, 2018
Package DI Number
20884521700724
Quantity per Package
5
Contains DI Package
10884521700727
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |