Drive - Raised Toilet Seat,4" Without Lid,1 EA - Drive Devilbiss Healthcare

Duns Number:867673159

Device Description: Raised Toilet Seat,4" Without Lid,1 EA

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More Product Details

Catalog Number

-

Brand Name

Drive

Version/Model Number

RTL12064

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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 Details

Product Code

ILS

Product Code Name

ADAPTOR, HYGIENE

Device Record Status

Public Device Record Key

923472b5-b680-4fbb-9985-930d67a87799

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 10, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DRIVE DEVILBISS HEALTHCARE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3783
2 A medical device with a moderate to high risk that requires special controls. 832