AVANT MIS 6400-310-2

GUDID 00193082150333

AVANT Supplementary Implants Caddy

SPINECRAFT, LLC

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID00193082150333
NIH Device Record Key12df78d4-b922-4f59-8b8a-6e1567b867ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameAVANT MIS
Version Model Number6400-310-2
Catalog Number6400-310-2
Company DUNS783908713
Company NameSPINECRAFT, LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com
Phone+1(630)920-7300
Emailinfo@spinecraft.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100193082150333 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00193082150333]

Moist Heat or Steam Sterilization


[00193082150333]

Moist Heat or Steam Sterilization


[00193082150333]

Moist Heat or Steam Sterilization


[00193082150333]

Moist Heat or Steam Sterilization


[00193082150333]

Moist Heat or Steam Sterilization


[00193082150333]

Moist Heat or Steam Sterilization


[00193082150333]

Moist Heat or Steam Sterilization


[00193082150333]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [AVANT MIS]

00193082111631AVANT Dilator No.3
00193082111624AVANT Dilator No.2
00193082111617AVANT Dilator No.1
00193082111600AVANT RCDF Sleeve, Slim, Gen III
00193082077333AVANT Extended Tab Anti-Torque
00193082077326Extended Tab Clip, Titanium
00193082077319Extended Tab Clip, Stainless Steel
00193082077289AVANT RCDF Sleeve, Slim
00193082077258AVANT Imaging Caliper
00193082077241AVANT Calipers
00193082077234Dia.5.5mm MIS Lordosed Rods Caddy
00193082077227Dia.6mm MIS Lordosed Rods Caddy
00193082077203AVANT MIS System Set Screw and Miscellaneous Implants Caddy
00193082077197AVANT MIS System ASTRA Implant Case w / Dye Sublimation Graphics
00193082077180AVANT Side Loading Counter Torque Handle
00193082077173AVANT Extended Tab Remover
00193082077166AVANT RCDF Sleeve
00193082077159AVANT T30 Self-retaining Driver Constant Shaft
00193082077142AVANT T30 Hexalobe Driver
00193082077135AVANT Polyaxial Screwdriver
00193082077128AVANT MIS System Instruments Case
00193082152832AVANT Low Extended Tab Remover, 3D Printed
00193082151347AVANT Calipers
00193082150333AVANT Supplementary Implants Caddy
00193082150302AVANT MIS System Instruments Case
00193082077272AVANT Imaging Caliper Scale for MIS Rods
00193082077265AVANT Imaging Caliper Scale for Lordosed Rods
00193082154768MIS NavLock Polyaxial Screwdriver
00193082153808RCDF Sleeve, Slim, Gen III
00193082153792Dilator no.3
00193082114151SpineCraft Universal Metal Lid
00193082077302Extended Tab Clip, Strong
00193082077296Extended Tab Clip, Extra Strong
00193082150326AVANT Set Screws and Miscellaneous Implants Caddy
00193082150319AVANT MIS System - ASTRA Implants Case

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