Duns Number:480151859
Device Description: Sanitary Cover to use with short-term patient positioning and stabilization device for MR Sanitary Cover to use with short-term patient positioning and stabilization device for MR and CT imaging.
Catalog Number
1101
Brand Name
Cover Multipad
Version/Model Number
Cover Multipad
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Product Code
KME
Product Code Name
Bedding, Disposable, Medical
Public Device Record Key
f59896b1-943e-402d-a213-9bd2f6e07f18
Public Version Date
May 20, 2022
Public Version Number
1
DI Record Publish Date
May 12, 2022
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 | 126 |