Duns Number:112164780
Device Description: Supine Lithotomy Trendelenburg Foam Positioning Kit
Catalog Number
FP-SLT
Brand Name
CARDINAL HEALTH
Version/Model Number
FP-SLT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 26, 2026
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
CCX
Product Code Name
SUPPORT, PATIENT POSITION
Public Device Record Key
ea31807e-a082-4d3a-a90f-81053e225b66
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
October 25, 2018
Package DI Number
50885380162198
Quantity per Package
6
Contains DI Package
10885380162190
Package Discontinue Date
March 26, 2026
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 | 81 |
2 | A medical device with a moderate to high risk that requires special controls. | 111 |