Duns Number:063519193
Device Description: TIDIShield Zero Gravity Covers Clear Polyethylene Sterile Fits Zero Gravity 20 per Case
Catalog Number
-
Brand Name
TIDIShield
Version/Model Number
ZGD20WA-LOOP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 22, 2022
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
PUI
Product Code Name
Drape, Surgical, Exempt
Public Device Record Key
e65af1d1-9fe9-4eea-8e94-80d7fa093183
Public Version Date
September 23, 2022
Public Version Number
4
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 |