Disposable Troop Elevation Pillow Addition - Disposable Troop Elevation Pillow Addition - 2 - CR ENTERPRISES, LLC

Duns Number:006375677

Device Description: Disposable Troop Elevation Pillow Addition - 2 per box

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More Product Details

Catalog Number

10-910-04

Brand Name

Disposable Troop Elevation Pillow Addition

Version/Model Number

10-910-04

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2021

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)

-

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

d4b9d9e9-8839-4f5b-b5a8-b065f1417ffd

Public Version Date

September 15, 2021

Public Version Number

2

DI Record Publish Date

April 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CR ENTERPRISES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7