Benefix™ Interspinous Fixation System - U&I CORPORATION

Duns Number:688811082

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More Product Details

Catalog Number

-

Brand Name

Benefix™ Interspinous Fixation System

Version/Model Number

IS30180

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

Yes

Prescription Use (Rx)

Yes

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

PEK

Product Code Name

Spinous process plate

Device Record Status

Public Device Record Key

7cdcc43c-bb14-4b87-a62e-316138883280

Public Version Date

June 17, 2019

Public Version Number

4

DI Record Publish Date

November 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"U&I CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2058
2 A medical device with a moderate to high risk that requires special controls. 10186
U Unclassified 24