Duns Number:961027315
Device Description: BAR DRAPE PACK
Catalog Number
SBA53SSVAB
Brand Name
CARDINAL HEALTH
Version/Model Number
SBA53SSVAB
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
PUI
Product Code Name
Drape, surgical, exempt
Public Device Record Key
8c65b565-fd58-422f-ba90-70d95f7a7906
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
May 06, 2020
Package DI Number
50888439821862
Quantity per Package
10
Contains DI Package
10888439821864
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 |