Duns Number:961027315
Device Description: TOWEL PACK 4
Catalog Number
SBA53TPMBA
Brand Name
CARDINAL HEALTH
Version/Model Number
SBA53TPMBA
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
FRL
Product Code Name
FIBER, MEDICAL, ABSORBENT
Public Device Record Key
55f76a76-006f-4bc4-be46-86128eb9de52
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
November 11, 2019
Package DI Number
50888439609279
Quantity per Package
56
Contains DI Package
10888439609271
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 |