Catalog Number

-

Brand Name

GENDRON

Version/Model Number

GS3648

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

3bee82f9-8a7b-4441-8477-3813fa3ed735

Public Version Date

August 17, 2020

Public Version Number

1

DI Record Publish Date

August 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-