Duns Number:096372255
Device Description: DRI-ANGLE/SILVER COATED W/ELEMENTS STRING
Catalog Number
32-2172
Brand Name
DeRoyal
Version/Model Number
32-2172
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
KHR
Product Code Name
ABSORBER, SALIVA, PAPER
Public Device Record Key
c63fa110-9792-4a19-b89e-946c761d610f
Public Version Date
August 31, 2021
Public Version Number
1
DI Record Publish Date
August 23, 2021
Package DI Number
50749756355341
Quantity per Package
25
Contains DI Package
00749756355346
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 |