Primary Device ID | 00813210020801 |
NIH Device Record Key | 92de898b-59b2-4053-8f13-ff365ddc6fd9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | VariLift-C |
Version Model Number | CIC2-A745 |
Company DUNS | 832543255 |
Company Name | WENZEL SPINE, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813210020801 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
[00813210020801]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-12-31 |
Device Publish Date | 2019-12-23 |
00813210020856 | The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, |
00813210020849 | The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, |
00813210020832 | The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, |
00813210020788 | Expander |
00813210020771 | Retainer |
00813210020764 | Inserter |
00813210020719 | Expansion Wrench, T-Handle |
00813210020702 | Insertion Wrench, T-Handle |
00813210020252 | Removal Screwdriver |
00813210020221 | Expansion Wrench |
00813210020214 | Locking Wrench |
00813210020207 | Insertion Wrench |
00813210020061 | The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, |
00813210020054 | The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, |
00813210020047 | The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, |
00813210020030 | The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, |
00813210021341 | VariLift-C Instrument Case |
00813210020825 | VariLift-C Unlocking Rod |
00813210020818 | VariLift-C 10mm Trial |
00813210020801 | VariLift-C 09mm Trial |
00813210020795 | VariLift-C 08mm Trial |
00813210020269 | Graft Ejector |
00813210020245 | Tap, 9.0mm |
00813210020238 | Tap, 7.5mm |