Duns Number:961027315
Device Description: OR TOWEL 18X30IN BLUE PREM 4PK
Catalog Number
28702-004A
Brand Name
CARDINAL HEALTH
Version/Model Number
28702-004A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2021
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
PUI
Product Code Name
Drape, surgical, exempt
Public Device Record Key
44cccd9c-5f05-46a6-9689-29672a89fdc9
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
June 08, 2020
Package DI Number
50888439814116
Quantity per Package
70
Contains DI Package
10888439814118
Package Discontinue Date
April 30, 2021
Package Status
Not 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 |