Duns Number:961027315
Device Description: Cardinal Health Tip Cleaner Cautery X-Ray Radiopaque Abrasive Foam Pad 2 in. x 2 in. Adhes Cardinal Health Tip Cleaner Cautery X-Ray Radiopaque Abrasive Foam Pad 2 in. x 2 in. Adhesive Backed blue
Catalog Number
100BN-P
Brand Name
CARDINAL HEALTH
Version/Model Number
100BN-P
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
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
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
0ba085a3-bd9e-4fe3-8b85-b9b5cc440385
Public Version Date
October 21, 2020
Public Version Number
2
DI Record Publish Date
October 08, 2020
Package DI Number
50885380113206
Quantity per Package
1000
Contains DI Package
10885380113208
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 |