Duns Number:942139841
Device Description: HoverMatt SPU Plus HoverCover
Catalog Number
HMHC-39
Brand Name
HoverMatt SPU Plus HoverCover
Version/Model Number
HMHC-39
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
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
FRZ
Product Code Name
Device, Patient Transfer, Powered
Public Device Record Key
e5822c77-a504-44cc-b9b8-4d9e8c25a28e
Public Version Date
October 04, 2022
Public Version Number
1
DI Record Publish Date
September 26, 2022
Package DI Number
00816299011708
Quantity per Package
10
Contains DI Package
00816299011715
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 72 |