Duns Number:961027315
Device Description: KIT, ROC DENTAL
Catalog Number
PECGDNRO4
Brand Name
CARDINAL HEALTH
Version/Model Number
PECGDNRO4
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
e0baec22-48e5-4e47-9567-df654f4106e8
Public Version Date
January 18, 2021
Public Version Number
1
DI Record Publish Date
January 10, 2021
Package DI Number
50888439974506
Quantity per Package
1
Contains DI Package
10888439974508
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 |