Drive - DS Divided Leg Sling, Sm,1/ea - Drive Devilbiss Healthcare

Duns Number:867673159

Device Description: DS Divided Leg Sling, Sm,1/ea

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More Product Details

Catalog Number

-

Brand Name

Drive

Version/Model Number

DS-13262S

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

FSA

Product Code Name

LIFT, PATIENT, NON-AC-POWERED

Device Record Status

Public Device Record Key

e0adb8cb-7482-45c3-ba7d-41b8c893ccd9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 10, 2017

Additional Identifiers

Package DI Number

50822383581151

Quantity per Package

12

Contains DI Package

00822383581156

Package Discontinue Date

-

Package Status

In Commercial Distribution

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