Catalog Number

-

Brand Name

Drive

Version/Model Number

13262M

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)

Yes

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

03492912-d8a3-4265-ac44-b92461d935ed

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 10, 2017

Package DI Number

50822383231629

Quantity per Package

12

Contains DI Package

00822383231624

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-