Duns Number:961027315
Device Description: ORP DENTAL PACK
Catalog Number
SENHDDPVC2
Brand Name
CARDINAL HEALTH
Version/Model Number
SENHDDPVC2
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
ba028efa-a766-4e16-971b-37b26397f6ff
Public Version Date
January 07, 2021
Public Version Number
1
DI Record Publish Date
December 30, 2020
Package DI Number
50888439970195
Quantity per Package
2
Contains DI Package
10888439970197
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 |