General Instruments

GUDID 00840180520529

Access Screw Distractor

ALPHATEC SPINE, INC.

Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable Surgical retraction system, reusable
Primary Device ID00840180520529
NIH Device Record Key22f76402-1b6d-42cb-91c0-97a4bbca02c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeneral Instruments
Version Model NumberCI-11382-10
Company DUNS602465783
Company NameALPHATEC 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 Datetrue
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(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com
Phone+1(760)431-9286
EmailRegulatory@alphatecspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840180520529 [Primary]

FDA Product Code

GADRETRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


[00840180520529]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-20
Device Publish Date2023-11-12

On-Brand Devices [General Instruments]

00811801037276Penfield 4 w/Larger Handle
00811801039973Ball Tip Probe, Rod Holder
00811801038204Heavy Guidewire Comb
00840180501221SHARP COBB, UP-ANGLED 22MM
00840180501214SHARP COBB, STRAIGHT 22MM
00840180501207SHARP COBB, DOWN-ANGLED 18MM
00840180501191SHARP COBB, UP-ANGLED 18MM
00840180501184SHARP COBB, STRAIGHT 18MM
00840180501177SHARP COBB, UP-ANGLED 12MM
00840180501160SHARP COBB, STRAIGHT 12MM
008401805011535mm Extra Wide Saddle Removal Tool
00840180501146Larger ALIF Tamp w/Teeth
00840180501139Size 4 Curette - Down 60Deg
00840180501122Size 2 Curette - 15Deg Up
00840180501115Closed Tulip Screwdriver
00840180501108Battalion, LLIF, 4th Blade w/ Large Handle, 12mm x 230mm
00840180501092Battalion, LLIF, 4th Blade w/ Large Handle, 12mm x 190mm
00840180501085Battalion, LLIF, 4th Blade w/ Large Handle, 8mm x 230mm
00840180501078Battalion, LLIF, 4th Blade w/ Large Handle, 8mm x 190mm
00840180501061Tamp w/ Center Pin, Straight
00840180501054Suction Cobb
00840180501047LIF Cup Curette, Offset Up Angled, Size 0
00840180501030Long Plate Holder
00840180501023Set Screw Inserter - 4" shorter
00840180501016Modular Compress-Distract Rack - Diener QC
00840180501009Stab and Grab Screwdriver - Short, no clip
0084018050099690 degree Head Turner - Extra long, large diameter
00840180500989Slap Hammer Adapter, Large Battalion Backend
00840180500972Slap Hammer Adapter, 1/4" Sq
00840180500965ACDF Nerve Hook
00840180500958Gear Shift Probe w/Radel Ball Handle
00840180500941STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 18MM
00840180500934STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 16MM
00840180500927STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 14MM
00840180500910STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 12MM
00840180500903STIRRUP SCRAPER, SINGLE SIDE - 18MM
00840180500897STIRRUP SCRAPER, SINGLE SIDE - 16MM
00840180500880STIRRUP SCRAPER, SINGLE SIDE - 14MM
00840180500873STIRRUP SCRAPER, SINGLE SIDE - 12MM
00840180500866STIRRUP SCRAPER, UP-ANGLED - 18MM
00840180500859STIRRUP SCRAPER, UP-ANGLED - 16MM
00840180500842STIRRUP SCRAPER, UP-ANGLED - 14MM
00840180500835STIRRUP SCRAPER, UP-ANGLED - 12MM
00840180500828STIRRUP SCRAPER - 18MM
00840180500811STIRRUP SCRAPER - 16MM
00840180500804STIRRUP SCRAPER - 14MM
00840180500798STIRRUP SCRAPER - 12MM
00840180500781Distractor, 10x5x25mm-15°
00840180500774Distractor, 9x5x25mm-15°
00840180500767Distractor, 8x5x25mm-15°

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