Primary Device ID | 10705034192727 |
NIH Device Record Key | 2db9abb0-d1a9-4cbb-b3e8-4bbdbb621733 |
Commercial Distribution Discontinuation | 2019-12-31 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SUMMIT |
Version Model Number | 274610100 |
Catalog Number | 274610100 |
Company DUNS | 107105876 |
Company Name | DEPUY SPINE, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
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(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx | |
Phone | +1(800)255-2500 |
xx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10705034192727 [Primary] |
HWR | DRIVER, PROSTHESIS |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
[10705034192727]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 6 |
Public Version Date | 2019-12-12 |
Device Publish Date | 2016-12-31 |
10705034193106 | SUMMIT FIXATION SYSTEM ANTI-CROSS THREAD DEVICE |
10705034192949 | SUMMIT SI OCT SPINAL FIXATION SYSTEM INSERTER |
10705034192932 | SUMMIT SI OCT SPINAL FIXATION SYSTEM PIN NUT INSERTER |
10705034192727 | SUMMIT FIXATION SYSTEM HEX DRIVER INSERTER 2.5mm |
10705034022901 | SUMMIT SI OCT SPINAL FIXATION SYSTEM DUAL WEDDING BAND ASSEMBLY 3.0/5.5mm |
10705034022857 | SUMMIT SI OCT SPINAL FIXATION SYSTEM DUAL DIAMETER ROD 3.0/ 5.5 X 600mm |
10705034022789 | SUMMIT SI OCT SPINAL FIXATION SYSTEM 3 HOLE INVERTED Y-PLATE 45mm |
10705034022772 | SUMMIT SI OCT SPINAL FIXATION SYSTEM 3 HOLE INVERTED Y-PLATE 37mm |
10705034022765 | SUMMIT SI OCT SPINAL FIXATION SYSTEM 3 HOLE INVERTED Y-PLATE 31mm |
10705034022758 | SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL INVERTED Y-PLATE 45mm |
10705034022727 | SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL T-PLATE 45mm |
10705034022710 | SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL T-PLATE 37mm |
10705034022703 | SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL T-PLATE 31mm |
10705034022673 | SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL T-PLATE 31mm |
10705034022352 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 4 x 50mm |
10705034022031 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 28mm |
10705034021942 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 10mm |
10705034021928 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 4 x 50mm |
10705034021911 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 4 x 48mm |
10705034021713 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 4 x 8mm |
10705034021706 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 50mm |
10705034021638 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 36mm |
10705034021621 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 34mm |
10705034021607 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 30mm |
10705034021591 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 28mm |
10705034021508 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 10mm |
10705034021119 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 50mm |
10705034021102 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 48mm |
10705034021096 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 46mm |
10705034021089 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 44mm |
10705034021072 | SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3.0 x 3.5 x 42mm |
10705034020679 | SUMMIT BONE SCREWS BONE SCREW 3.5 x 10mm |
10705034192666 | SUMMIT FIXATION SYSTEM DRILL 2mm |
10705034193564 | SUMMIT SI OCT SPINAL FIXATION SYSTEM DEPTH GAUGE 6-50mm Plus or Minus 15 Percent |
10705034193557 | SUMMIT SI OCT SPINAL FIXATION SYSTEM OCCIPITAL BONE SCREW GAUGE |
10705034193540 | SUMMIT SI OCT SPINAL FIXATION SYSTEM FIXED DEPTH GUIDE 14/16mm |
10705034193533 | SUMMIT SI OCT SPINAL FIXATION SYSTEM FIXED DEPTH GUIDE 10/12mm |
10705034193526 | SUMMIT SI OCT SPINAL FIXATION SYSTEM FIXED DEPTH GUIDE 6/8mm |
10705034193496 | SUMMIT SI OCT SPINAL FIXATION SYSTEM TEMPLATE, DUAL DIAMETER ROD 420mm |
10705034193489 | SUMMIT SI OCT SPINAL FIXATION SYSTEM TEMPLATE, TRANSITION ROD 3/4/3mm |
10705034193465 | SUMMIT SI OCT SPINAL FIXATION SYSTEM X20 HEXLOBE DRIVER ASSEMBLY |
10705034193458 | SUMMIT SI OCT SPINAL FIXATION SYSTEM HEX DRIVER SHAFT 2.0mm |
10705034193441 | SUMMIT OCT SPINAL FIXATION SYSTEM TORQUE LIMITING DRIVER |
10705034193427 | SUMMIT OCT SPINAL FIXATION SYSTEM TEMPLATE, INVERTED-Y PLATE 37mm |
10705034193410 | SUMMIT OCT SPINAL FIXATION SYSTEM TEMPLATE, INVERTED-Y PLATE 31mm |
10705034193373 | SUMMIT SI OCT SPINAL FIXATION SYSTEM T-PLATE TEMPLATE 45mm |
10705034193366 | SUMMIT SI OCT SPINAL FIXATION SYSTEM T-PLATE TEMPLATE 37mm |
10705034193304 | SUMMIT SI OCT SPINAL FIXATION SYSTEM INSERTION SOCKET WRENCH |
10705034193298 | SUMMIT SI OCT SPINAL FIXATION SYSTEM NUT DRIVER |
10705034193274 | SUMMIT SI OCT SPINAL FIXATION SYSTEM HEX DRIVER, MINIMAL ACCESS 2.5mm |