Duns Number:961027315
Device Description: STERILE FOAM POSITIONER PACK
Catalog Number
SBA13FPLRB
Brand Name
CARDINAL HEALTH
Version/Model Number
SBA13FPLRB
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
CCX
Product Code Name
SUPPORT, PATIENT POSITION
Public Device Record Key
8a6afb56-a351-44d2-b3d5-63cf7646fc7a
Public Version Date
November 08, 2019
Public Version Number
5
DI Record Publish Date
December 05, 2017
Package DI Number
50887488877080
Quantity per Package
20
Contains DI Package
10887488877082
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 |