CARDINAL HEALTH - Supine Lithotomy Trendelenburg Foam Positioning - CARDINAL HEALTH 200, LLC

Duns Number:112164780

Device Description: Supine Lithotomy Trendelenburg Foam Positioning Kit

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More Product Details

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

Product Characteristics

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 Details

Product Code

CCX

Product Code Name

SUPPORT, PATIENT POSITION

Device Record Status

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

Additional Identifiers

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

"CARDINAL HEALTH 200, LLC" Characteristics
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