VariLift-L

GUDID 00813210020757

13-15mm Extended Inserter

WENZEL SPINE, INC.

Orthopaedic implant inserter/extractor, reusable
Primary Device ID00813210020757
NIH Device Record Key6661788b-2040-4364-9055-02a83a31f4fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameVariLift-L
Version Model NumberCIE2-A023-C01
Company DUNS832543255
Company NameWENZEL SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com
Phone855-936-9351
Emailinfo@wenzelspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813210020757 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


[00813210020757]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2016-09-19

On-Brand Devices [VariLift-L]

0081321002075713-15mm Extended Inserter
0081321002074010-12mm Extended Inserter
00813210020566Inserter, 10mm-12mm, Molded Handle
008132100205599/11mm Retainer
00813210020474Reducer, Molded Handle
00813210020467Expander
0081321002045013/15mm Retainer
00813210020443Inserter, 13mm-15mm, Molded Handle
0081321002043613-15mm TR8 Extended Retainer
0081321002042910-12mm TR8 Extended Retainer
0081321002041224/28mm Extended Expander
00813210020405Extended Reducer, Ti Handle
0081321002039913-15mm Extended Inserter
0081321002038210-12mm Extended Inserter
00813210020023The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device wi
00813210020016The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device wi
00813210020009The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device wi
0081321002063415mm Threaded Trial
0081321002062714mm Threaded Trial
0081321002061013mm Threaded Trial
0081321002060312mm Threaded Trial
0081321002059711mm Threaded Trial
0081321002058010mm Threaded Trial
00813210020573Retainer Alignment Guide
00813210020542Inserter Alignment Guide
00813210020306Insertion Wrench Alignment Guide

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