Overbed Table with U-Base - Overbed Table with U-Base, Mahogany and White, - DYNAREX CORPORATION

Duns Number:008124539

Device Description: Overbed Table with U-Base, Mahogany and White, 32"x16", Adjustable Height 28" to 43"

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More Product Details

Catalog Number

-

Brand Name

Overbed Table with U-Base

Version/Model Number

10454

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

KMN

Product Code Name

Chair And Table, Medical

Device Record Status

Public Device Record Key

8c2eb0d7-eda4-4da8-b7f2-01f4e32979e3

Public Version Date

September 09, 2021

Public Version Number

1

DI Record Publish Date

September 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2