GEO Bone Screw System

GUDID B471101030380

Bone Screw 3x38 Headed Long Thread Cannulated Ti

GRAMERCY EXTREMITY ORTHOPEDICS LLC

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDB471101030380
NIH Device Record Key818c71d5-13d2-4e03-970c-734965c2f5c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEO Bone Screw System
Version Model Number10103038
Company DUNS080068420
Company NameGRAMERCY EXTREMITY ORTHOPEDICS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho

Device Dimensions

Outer Diameter3 Millimeter
Length38 Millimeter
Outer Diameter3 Millimeter
Length38 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB471101030380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-12
Device Publish Date2018-10-10

On-Brand Devices [GEO Bone Screw System]

B471712800060Washer Pack (2) for 8mm Bone Screw
B471712800050Washer Pack (2) for 7mm Bone Screw
B471712800040Washer Pack (2) for 5mm Bone Screw
B471712800030Washer Pack (2) for 4mm Bone Screw
B471712800020Washer Pack (2) for 3mm Bone Screw
B471712800010Washer Pack (2) for 2mm Bone Screw
B471711300060K-Wire Pack (2) 2.5mmx230mm for 7mm/8mm Bone Screw
B471711300050K-Wire Pack (2) 2.5mmx150mm for 7mm/8mm Bone Screw
B471711300040K-Wire Pack (2) 1.6mmx150mm for 4mm/5mm Bone Screw
B471711300030K-Wire Pack (2) 1.6mmx100mm for 4mm/5mm Bone Screw
B471711300020K-Wire Pack (2) 1.2mmx100mm for 3mm Bone Screw
B471711300010K-Wire Pack (2) 0.9mmx100mm for 2mm Bone Screw
B471701000130Instrument Kit for 7mm/8mm Bone Screw, 230mm K-Wire
B471701000120Instrument Kit for 7mm/8mm Bone Screw, 150mm K-Wire
B471701000070Instrument Kit for 4mm/5mm Bone Screw
B471701000020Instrument Kit for 3mm Bone Screw
B471701000010Instrument Kit for 2mm Bone Screw
B471280000080Washer for 8mm Bone Screw
B471280000070Washer for 7mm Bone Screw
B471280000050Washer for 5mm Bone Screw
B471280000040Washer for 4mm Bone Screw
B471280000030Washer for 3mm Bone Screw
B471280000020Washer for 2mm Bone Screw
B471270101500Depth Gauge for 100mm/150mm K-Wires
B471270002300Depth Gauge for 230mm Guide Wire
B471270001000Depth Gauge for 100mm K-Wire
B471231000910Countersink Tip 7mm/8mm Bone Screw Hudson
B471230000660Countersink Tip 4mm/5mm Bone Screw AO
B471230000410Countersink Tip 2mm/3mm Bone Screw AO
B471212502300Drill Bit 5.0mmx230mm ZH Cannulated
B471212501600Drill Bit 5.0mmx160mm ZH Cannulated
B471210281500Drill Bit 2.8mmx150mm AO Cannulated
B471210281000Drill Bit 2.8mmx100mm AO Cannulated
B471210201000Drill Bit 2.0mmx100mm AO Cannulated
B471201910000Driver Handle Hudson Ratchet Straight Reusable
B471201099300Driver Tip Hexalobe T-30 Hudson SS
B471201099200Driver Tip Hexalobe T-20 Hudson SS
B471200920000Driver Handle AO Fixed Spinner Straight Reusable
B471200099200Driver Tip Hexalobe T-20 AO SS
B471200099100Driver Tip Hexalobe T-10 AO SS
B471200099080Driver Tip Hexalobe T-8 AO SS
B471132252300K-Wire 2.5mmx230mm Single Threaded Tip
B471132251500K-Wire 2.5mmx150mm Single Threaded Tip
B471132161500K-Wire 1.6mmx150mm Single Threaded Tip
B471132161000K-Wire 1.6mmx100mm Single Threaded Tip
B471131091000K-Wire 0.9mmx100mm Double Smooth Tip
B471130252300K-Wire 2.5mmx230mm Single Smooth Tip
B471130251500K-Wire 2.5mmx150mm Single Smooth Tip
B471130161500K-Wire 1.6mmx150mm Single Smooth Tip
B471130161000K-Wire 1.6mmx100mm Single Smooth Tip

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