Lancer Open Pedicle Screw System

GUDID 00840996177382

Tapered Cannulated T25 Driver

Choice Spine, LP

External spinal fixation system
Primary Device ID00840996177382
NIH Device Record Keyb367192a-e949-4227-9bd9-cea370d0769c
Commercial Distribution StatusIn Commercial Distribution
Brand NameLancer Open Pedicle Screw System
Version Model NumberM070-0133
Company DUNS078293017
Company NameChoice Spine, LP
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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

Phone+1(865)246-3333
Emailinfo@choicespine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996177382 [Primary]

FDA Product Code

LHXTrousers, anti-shock

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996177382]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-28
Device Publish Date2019-06-20

On-Brand Devices [Lancer Open Pedicle Screw System]

00840996177382Tapered Cannulated T25 Driver
00840996175067LANCER,DRIVER,HEXALOBE,TAPERED
00840996174701LANCER,POSITIONER,TULIP,T-HANDLE
00840996172936LANCER,PEDICLE PROBE
00840996170307LANCER,PROBE-TAP,1/4"COMBINATION

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