Duns Number:063519193
Device Description: TIDIShield Equipment Covers Clear Polyethylene Fits Toshiba Aquilion-4 through Aquilion-64 TIDIShield Equipment Covers Clear Polyethylene Fits Toshiba Aquilion-4 through Aquilion-64 10 per Case
Catalog Number
-
Brand Name
TIDIShield
Version/Model Number
9053
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2021
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KKX
Product Code Name
Drape, surgical
Public Device Record Key
719fdb05-8c4f-46c7-a8c6-b3b4da0d8b3a
Public Version Date
May 03, 2021
Public Version Number
3
DI Record Publish Date
October 12, 2016
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 | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |