Catalog Number

-

Brand Name

Drive

Version/Model Number

15011

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

FMW

Product Code Name

COVER, MATTRESS (MEDICAL PURPOSES)

Public Device Record Key

a361aa61-54f4-4235-aa63-f1f76fd81377

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 19, 2017

Package DI Number

50822383104046

Quantity per Package

36

Contains DI Package

00822383104041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-