MediChoice - Cushion Seat Pressure Relieving Foam - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: Cushion Seat Pressure Relieving Foam Medium-Density 300 Pound 18 X 16 X 4 Inch Not Made Wi Cushion Seat Pressure Relieving Foam Medium-Density 300 Pound 18 X 16 X 4 Inch Not Made With Natural Rubber Latex MediChoice

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More Product Details

Catalog Number

-

Brand Name

MediChoice

Version/Model Number

WCC1816M

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

-

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

IMP

Product Code Name

CUSHION, WHEELCHAIR

Device Record Status

Public Device Record Key

3f4fb9cc-14fa-4861-920f-59e92d3de37a

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

October 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OWENS & MINOR DISTRIBUTION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 428
2 A medical device with a moderate to high risk that requires special controls. 8754
U Unclassified 1