Catalog Number

HM34SPU-HLF-B

Brand Name

Single Patient Use HoverMatt

Version/Model Number

HM34SPU-HLF-B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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"

Yes

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

FRZ

Product Code Name

DEVICE, PATIENT TRANSFER, POWERED

Public Device Record Key

6a399819-8192-4f86-b9f6-9cb031a268e8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 06, 2017

Package DI Number

00816299011074

Quantity per Package

10

Contains DI Package

00816299011081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box