CARDINAL HEALTH - SLT Arm Protector Foam Positioner - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: SLT Arm Protector Foam Positioner

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More Product Details

Catalog Number

FP-SLTARM

Brand Name

CARDINAL HEALTH

Version/Model Number

FP-SLTARM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

8f30aec8-776a-48cb-be73-6e27f7d58c1e

Public Version Date

October 28, 2020

Public Version Number

3

DI Record Publish Date

August 28, 2018

Additional Identifiers

Package DI Number

50885380162204

Quantity per Package

6

Contains DI Package

10885380162206

Package Discontinue Date

-

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 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