Duns Number:096372255
Device Description: ARM PROTECTORS
Catalog Number
9262-00
Brand Name
DeRoyal
Version/Model Number
9262-00
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
-
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
c0056d8d-81aa-45c8-9784-29ff305d6cbf
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
July 09, 2021
Package DI Number
50749756562008
Quantity per Package
12
Contains DI Package
00749756562003
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 |