Duns Number:961027315
Device Description: ORP DENTAL PACK
Catalog Number
SENHDDPVC1
Brand Name
CARDINAL HEALTH
Version/Model Number
SENHDDPVC1
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
OFX
Product Code Name
General purpose dental tray
Public Device Record Key
72ca40cd-a43c-4f22-bc88-1f05738a0631
Public Version Date
December 25, 2020
Public Version Number
1
DI Record Publish Date
December 17, 2020
Package DI Number
50888439963937
Quantity per Package
2
Contains DI Package
10888439963939
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |