VariLift-LX - Extended End Cap Driver - WENZEL SPINE, INC.

Duns Number:832543255

Device Description: Extended End Cap Driver

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


More Product Details

Catalog Number

-

Brand Name

VariLift-LX

Version/Model Number

CIE2-A506

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)

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

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Device Record Status

Public Device Record Key

07bf65a6-f9d7-452c-a3c2-a6879a2e8a96

Public Version Date

May 08, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WENZEL SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 46
2 A medical device with a moderate to high risk that requires special controls. 71
U Unclassified 9