Duns Number:825137818
Device Description: MANDRELS RA FOR F & P DISCS
Catalog Number
9510423
Brand Name
Darby Dental Supply, LLC
Version/Model Number
9510423
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EHJ
Product Code Name
DISK, ABRASIVE
Public Device Record Key
44e7ebb6-2acd-41be-b013-f36f18ff49d0
Public Version Date
July 10, 2020
Public Version Number
1
DI Record Publish Date
July 02, 2020
Package DI Number
00889813046395
Quantity per Package
10
Contains DI Package
00889813046388
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1457 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 194 |
| U | Unclassified | 2 |