Duns Number:078766464
Device Description: A box of 10 procedural sets that include replacement foam for the Temporal Monitoring Head A box of 10 procedural sets that include replacement foam for the Temporal Monitoring Headframe.
Catalog Number
NA-DSP3PK
Brand Name
Temporal Monitoring Headframe Foam Procedural Set, Packaged 10-Pack
Version/Model Number
NA-DSP3PK
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
K160442
Product Code
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
040d5be5-de4c-4f4d-baed-648d72d10058
Public Version Date
August 19, 2022
Public Version Number
3
DI Record Publish Date
June 05, 2020
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. | 18 |