Single Patient Use HoverMatt - 34" Single Patient Use Split Leg HoverMatt - Hovertech International

Duns Number:942139841

Device Description: 34" Single Patient Use Split Leg HoverMatt

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More Product Details

Catalog Number

HM34SPU-Split

Brand Name

Single Patient Use HoverMatt

Version/Model Number

HM34SPU-Split

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FRZ

Product Code Name

DEVICE, PATIENT TRANSFER, POWERED

Device Record Status

Public Device Record Key

3ae11d0d-ff1d-4182-9732-512dcadebdc7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 30, 2016

Additional Identifiers

Package DI Number

00816299010879

Quantity per Package

10

Contains DI Package

00816299010886

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"HOVERTECH INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 72