Catalog Number

-

Brand Name

Optimum Gel Wheelchair Cushion - 18 x 18 x 3

Version/Model Number

HDC-9B 18X18

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IMP

Product Code Name

Cushion, Wheelchair

Public Device Record Key

d00665e9-42f9-4aeb-b22b-e78438061ec4

Public Version Date

May 10, 2021

Public Version Number

3

DI Record Publish Date

November 11, 2020

Package DI Number

30815067043317

Quantity per Package

4

Contains DI Package

00815067043316

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton