Primary Device ID | 00193082152832 |
NIH Device Record Key | 0fceaf23-d1b1-493f-b6e3-45e0f2838a29 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AVANT MIS |
Version Model Number | 6400-91-3D |
Catalog Number | 6400-91-3D |
Company DUNS | 783908713 |
Company Name | SPINECRAFT, LLC |
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 | true |
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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com | |
Phone | +1(630)920-7300 |
info@spinecraft.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00193082152832 [Primary] |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
[00193082152832]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-10-26 |
Device Publish Date | 2020-10-16 |
00193082111631 | AVANT Dilator No.3 |
00193082111624 | AVANT Dilator No.2 |
00193082111617 | AVANT Dilator No.1 |
00193082111600 | AVANT RCDF Sleeve, Slim, Gen III |
00193082077333 | AVANT Extended Tab Anti-Torque |
00193082077326 | Extended Tab Clip, Titanium |
00193082077319 | Extended Tab Clip, Stainless Steel |
00193082077289 | AVANT RCDF Sleeve, Slim |
00193082077258 | AVANT Imaging Caliper |
00193082077241 | AVANT Calipers |
00193082077234 | Dia.5.5mm MIS Lordosed Rods Caddy |
00193082077227 | Dia.6mm MIS Lordosed Rods Caddy |
00193082077203 | AVANT MIS System Set Screw and Miscellaneous Implants Caddy |
00193082077197 | AVANT MIS System ASTRA Implant Case w / Dye Sublimation Graphics |
00193082077180 | AVANT Side Loading Counter Torque Handle |
00193082077173 | AVANT Extended Tab Remover |
00193082077166 | AVANT RCDF Sleeve |
00193082077159 | AVANT T30 Self-retaining Driver Constant Shaft |
00193082077142 | AVANT T30 Hexalobe Driver |
00193082077135 | AVANT Polyaxial Screwdriver |
00193082077128 | AVANT MIS System Instruments Case |
00193082152832 | AVANT Low Extended Tab Remover, 3D Printed |
00193082151347 | AVANT Calipers |
00193082150333 | AVANT Supplementary Implants Caddy |
00193082150302 | AVANT MIS System Instruments Case |
00193082077272 | AVANT Imaging Caliper Scale for MIS Rods |
00193082077265 | AVANT Imaging Caliper Scale for Lordosed Rods |
00193082154768 | MIS NavLock Polyaxial Screwdriver |
00193082153808 | RCDF Sleeve, Slim, Gen III |
00193082153792 | Dilator no.3 |
00193082114151 | SpineCraft Universal Metal Lid |
00193082077302 | Extended Tab Clip, Strong |
00193082077296 | Extended Tab Clip, Extra Strong |
00193082150326 | AVANT Set Screws and Miscellaneous Implants Caddy |
00193082150319 | AVANT MIS System - ASTRA Implants Case |
00193082152535 | AVANT Set Screw Loading Post |
00193082152528 | AIM Fulcrum Block, 35mm x 45mm |
00193082152511 | AIM Fulcrum Block, 35mm x 40mm |
00193082152504 | AIM Fulcrum Block, 30mm x 40mm |
00193082152498 | AIM Fulcrum Block, 30mm x 35mm |
00193082152481 | AIM Fulcrum Block, 25mm x 35mm |
00193082152474 | AIM Fulcrum Block, 25mm x 30mm |
00193082152467 | AIM Fulcrum Block, 20mm x 30mm |
00193082152450 | AIM Fulcrum Block, 20mm x 25mm |
00193082152443 | AIM Fulcrum Block, 15mm x 25mm |
00193082150241 | AIM Fulcrum Block, 15mm x 20mm |
00193082150234 | AVANT Extended Tab Remover |