Duns Number:096372255
Device Description: Foam Positioner, Body 18 in x11 in X8 in 6/cs
Catalog Number
M60-032A
Brand Name
DeRoyal
Version/Model Number
M60-032A
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
CCX
Product Code Name
SUPPORT, PATIENT POSITION
Public Device Record Key
c6eb7cdb-28f6-4fbf-a51a-6398650c64b5
Public Version Date
August 05, 2021
Public Version Number
1
DI Record Publish Date
July 28, 2021
Package DI Number
50749756965557
Quantity per Package
6
Contains DI Package
00749756965552
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 |