Catalog Number

MFG-1-42000

Brand Name

Entree

Version/Model Number

Entree Lift

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

5cd443dc-449c-4adf-be93-74806662dd8b

Public Version Date

October 21, 2021

Public Version Number

1

DI Record Publish Date

October 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-