Assembly Required Distributors - Solid Seat for 24" alum WC - burgandy vinyl - ASSEMBLY REQUIRED DISTRIBUTORS INC

Duns Number:170562396

Device Description: Solid Seat for 24" alum WC - burgandy vinyl

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More Product Details

Catalog Number

-

Brand Name

Assembly Required Distributors

Version/Model Number

UP1403X-05

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

IMP

Product Code Name

Cushion, Wheelchair

Device Record Status

Public Device Record Key

51af752a-39ae-43e6-8b05-ae2f347e7c97

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

March 21, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ASSEMBLY REQUIRED DISTRIBUTORS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 81
2 A medical device with a moderate to high risk that requires special controls. 8