Duns Number:096372255
Device Description: Custom 2 x 2 Ortho Felt
Catalog Number
32-2088
Brand Name
DeRoyal
Version/Model Number
32-2088
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
FMP
Product Code Name
Protector, skin pressure
Public Device Record Key
84e76f97-4fc4-428a-ad24-a31785c12815
Public Version Date
December 08, 2021
Public Version Number
2
DI Record Publish Date
July 12, 2021
Package DI Number
50749756913633
Quantity per Package
20
Contains DI Package
00749756913638
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 |