Duns Number:961027315
Device Description: CPT CLOTH DRAPE JAMES
Catalog Number
SBA33DJOUB
Brand Name
CARDINAL HEALTH
Version/Model Number
SBA33DJOUB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 03, 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
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
0c64fc74-3451-489e-b0fc-5afca803980a
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
October 02, 2018
Package DI Number
50888439115176
Quantity per Package
10
Contains DI Package
10888439115178
Package Discontinue Date
March 03, 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 |