Catalog Number

-

Brand Name

Handi-Move Rail System

Version/Model Number

3950 00000001

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FSA

Product Code Name

Lift, patient, non-ac-powered

Public Device Record Key

2903cdf8-8c7f-4232-9fef-7ac0c85eaecd

Public Version Date

August 26, 2021

Public Version Number

1

DI Record Publish Date

August 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-