DRIVEMEDICAL - PowerFolding Power Product Description: Crutch - Drive Devilbiss Healthcare

Duns Number:867673159

Device Description: PowerFolding Power Product Description: Crutch Holder Set, SType, 1/ea

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More Product Details

Catalog Number

-

Brand Name

DRIVEMEDICAL

Version/Model Number

SF8050

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 01, 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

-

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

KNN

Product Code Name

COMPONENTS, WHEELCHAIR

Device Record Status

Public Device Record Key

eb763de5-eac4-40b0-b909-58a174fae271

Public Version Date

July 16, 2019

Public Version Number

3

DI Record Publish Date

May 19, 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