Duns Number:961027315
Device Description: Absorbent Towel
Catalog Number
7550CE
Brand Name
CARDINAL HEALTH
Version/Model Number
7550CE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 02, 2023
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)
-
Over the Counter (OTC)
Yes
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
a41c336b-cde3-4785-8366-cfeee1d5f4c9
Public Version Date
August 03, 2021
Public Version Number
5
DI Record Publish Date
June 23, 2016
Package DI Number
50630140030220
Quantity per Package
120
Contains DI Package
00630140030225
Package Discontinue Date
March 02, 2023
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 |