Duns Number:942139841
Device Description: 39" Single Patient Use HoverMatt Half Matt Breathable
Catalog Number
HM39SPU-HLF-TVA-B
Brand Name
Single Patient Use HoverMatt
Version/Model Number
HM39SPU-HLF-TVA-B
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
7a00ac61-d968-4fac-abab-e54910a5ba27
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 06, 2017
Package DI Number
00816299010480
Quantity per Package
10
Contains DI Package
00816299010718
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 |