Duns Number:096372255
Device Description: ReMuv Air Half Mat
Catalog Number
3778
Brand Name
DeRoyal
Version/Model Number
3778
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMR
Product Code Name
DEVICE, TRANSFER, PATIENT, MANUAL
Public Device Record Key
127082e2-41f9-491a-9980-a3e74604c558
Public Version Date
September 22, 2021
Public Version Number
1
DI Record Publish Date
September 14, 2021
Package DI Number
50749756376339
Quantity per Package
10
Contains DI Package
00749756376334
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7041 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
| U | Unclassified | 3 |