Catalog Number

GS4054DW

Brand Name

Gendron

Version/Model Number

GS4054DW

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

FNL

Product Code Name

Bed, Ac-Powered Adjustable Hospital

Public Device Record Key

eb066cf2-9d73-4d9e-a25c-ff167f8fe2aa

Public Version Date

November 16, 2020

Public Version Number

1

DI Record Publish Date

November 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-