Primary Device ID | B471101030260 |
NIH Device Record Key | 0757289b-adf2-4a66-b804-685210479a7b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GEO Bone Screw System |
Version Model Number | 10103026 |
Company DUNS | 080068420 |
Company Name | GRAMERCY EXTREMITY ORTHOPEDICS LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(855)436-2278 |
GEOSupportCenter@gramercyortho | |
Phone | +1(855)436-2278 |
GEOSupportCenter@gramercyortho |
Outer Diameter | 3 Millimeter |
Length | 26 Millimeter |
Outer Diameter | 3 Millimeter |
Length | 26 Millimeter |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B471101030260 [Primary] |
HWC | Screw, fixation, bone |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-11-12 |
Device Publish Date | 2018-10-10 |
B471712800060 | Washer Pack (2) for 8mm Bone Screw |
B471712800050 | Washer Pack (2) for 7mm Bone Screw |
B471712800040 | Washer Pack (2) for 5mm Bone Screw |
B471712800030 | Washer Pack (2) for 4mm Bone Screw |
B471712800020 | Washer Pack (2) for 3mm Bone Screw |
B471712800010 | Washer Pack (2) for 2mm Bone Screw |
B471711300060 | K-Wire Pack (2) 2.5mmx230mm for 7mm/8mm Bone Screw |
B471711300050 | K-Wire Pack (2) 2.5mmx150mm for 7mm/8mm Bone Screw |
B471711300040 | K-Wire Pack (2) 1.6mmx150mm for 4mm/5mm Bone Screw |
B471711300030 | K-Wire Pack (2) 1.6mmx100mm for 4mm/5mm Bone Screw |
B471711300020 | K-Wire Pack (2) 1.2mmx100mm for 3mm Bone Screw |
B471711300010 | K-Wire Pack (2) 0.9mmx100mm for 2mm Bone Screw |
B471701000130 | Instrument Kit for 7mm/8mm Bone Screw, 230mm K-Wire |
B471701000120 | Instrument Kit for 7mm/8mm Bone Screw, 150mm K-Wire |
B471701000070 | Instrument Kit for 4mm/5mm Bone Screw |
B471701000020 | Instrument Kit for 3mm Bone Screw |
B471701000010 | Instrument Kit for 2mm Bone Screw |
B471280000080 | Washer for 8mm Bone Screw |
B471280000070 | Washer for 7mm Bone Screw |
B471280000050 | Washer for 5mm Bone Screw |
B471280000040 | Washer for 4mm Bone Screw |
B471280000030 | Washer for 3mm Bone Screw |
B471280000020 | Washer for 2mm Bone Screw |
B471270101500 | Depth Gauge for 100mm/150mm K-Wires |
B471270002300 | Depth Gauge for 230mm Guide Wire |
B471270001000 | Depth Gauge for 100mm K-Wire |
B471231000910 | Countersink Tip 7mm/8mm Bone Screw Hudson |
B471230000660 | Countersink Tip 4mm/5mm Bone Screw AO |
B471230000410 | Countersink Tip 2mm/3mm Bone Screw AO |
B471212502300 | Drill Bit 5.0mmx230mm ZH Cannulated |
B471212501600 | Drill Bit 5.0mmx160mm ZH Cannulated |
B471210281500 | Drill Bit 2.8mmx150mm AO Cannulated |
B471210281000 | Drill Bit 2.8mmx100mm AO Cannulated |
B471210201000 | Drill Bit 2.0mmx100mm AO Cannulated |
B471201910000 | Driver Handle Hudson Ratchet Straight Reusable |
B471201099300 | Driver Tip Hexalobe T-30 Hudson SS |
B471201099200 | Driver Tip Hexalobe T-20 Hudson SS |
B471200920000 | Driver Handle AO Fixed Spinner Straight Reusable |
B471200099200 | Driver Tip Hexalobe T-20 AO SS |
B471200099100 | Driver Tip Hexalobe T-10 AO SS |
B471200099080 | Driver Tip Hexalobe T-8 AO SS |
B471132252300 | K-Wire 2.5mmx230mm Single Threaded Tip |
B471132251500 | K-Wire 2.5mmx150mm Single Threaded Tip |
B471132161500 | K-Wire 1.6mmx150mm Single Threaded Tip |
B471132161000 | K-Wire 1.6mmx100mm Single Threaded Tip |
B471131091000 | K-Wire 0.9mmx100mm Double Smooth Tip |
B471130252300 | K-Wire 2.5mmx230mm Single Smooth Tip |
B471130251500 | K-Wire 2.5mmx150mm Single Smooth Tip |
B471130161500 | K-Wire 1.6mmx150mm Single Smooth Tip |
B471130161000 | K-Wire 1.6mmx100mm Single Smooth Tip |