VariLift-C

GUDID 00813210020719

Expansion Wrench, T-Handle

WENZEL SPINE, INC.

Orthopaedic implant/instrument assembling device
Primary Device ID00813210020719
NIH Device Record Keyc4420685-b00a-4e85-ab64-5f78fae039b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameVariLift-C
Version Model NumberCIC1-A743-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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813210020719 [Primary]

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


[00813210020719]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-05-08
Device Publish Date2016-09-19

On-Brand Devices [VariLift-C]

00813210020856The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
00813210020849The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
00813210020832The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
00813210020788Expander
00813210020771Retainer
00813210020764Inserter
00813210020719Expansion Wrench, T-Handle
00813210020702Insertion Wrench, T-Handle
00813210020252Removal Screwdriver
00813210020221Expansion Wrench
00813210020214Locking Wrench
00813210020207Insertion Wrench
00813210020061The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
00813210020054The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
00813210020047The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
00813210020030The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping,
00813210021341VariLift-C Instrument Case
00813210020825VariLift-C Unlocking Rod
00813210020818VariLift-C 10mm Trial
00813210020801VariLift-C 09mm Trial
00813210020795VariLift-C 08mm Trial
00813210020269Graft Ejector
00813210020245Tap, 9.0mm
00813210020238Tap, 7.5mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.