Hovertech - Hovertech Hovermatt 50" W x 78" L - HYGIA HEALTH SERVICES, INC.

Duns Number:177939027

Device Description: Hovertech Hovermatt 50" W x 78" L

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More Product Details

Catalog Number

-

Brand Name

Hovertech

Version/Model Number

HM50SPU

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 10, 2019

Issuing Agency

In GS1

Product Characteristics

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

Yes

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 Details

Product Code

FRZ

Product Code Name

Device, Patient Transfer, Powered

Device Record Status

Public Device Record Key

71221507-1e83-42fd-ba2a-7349c0bb6048

Public Version Date

March 19, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

30817357021937

Quantity per Package

5

Contains DI Package

10817357021933

Package Discontinue Date

March 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Box

"HYGIA HEALTH SERVICES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 49
2 A medical device with a moderate to high risk that requires special controls. 178