Wipe Down Cushion - Wipe Down Cushion (16" x 18" x 4.5") - PRIMO INC

Duns Number:958758146

Device Description: Wipe Down Cushion (16" x 18" x 4.5")

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More Product Details

Catalog Number

DUPC1618

Brand Name

Wipe Down Cushion

Version/Model Number

DUPC1618

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"

-

For Single-Use

-

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

FMP

Product Code Name

Protector, Skin Pressure

Device Record Status

Public Device Record Key

6a6cee73-dda2-4bd4-a8eb-aa5835d8c499

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

February 20, 2019

Additional Identifiers

Package DI Number

00810006680645

Quantity per Package

10

Contains DI Package

00810006680256

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"PRIMO INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 208