Ø7.5mm x 40mm Pedicle Reduction Screw with Set Screw Package - XENCO MEDICAL LLC

Duns Number:079282130

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Ø7.5mm x 40mm Pedicle Reduction Screw with Set Screw Package

Version/Model Number

XM-235-7540

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Device Record Status

Public Device Record Key

7ca5e7f8-0383-4c6a-af6a-e522918d9a6f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 30, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"XENCO MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 190