| Primary Device ID | 20811998030252 |
| NIH Device Record Key | c568b62b-2f2e-40b9-ada1-27b568e193d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OIC Cannulated Screw System |
| Version Model Number | 28-300P |
| Company DUNS | 070061160 |
| Company Name | ORTHOPAEDIC IMPLANT COMPANY, THE |
| Device Count | 6 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 775 636 8281 |
| Info@OrthoImplantCompany.com | |
| Phone | 775 636 8281 |
| Info@OrthoImplantCompany.com |
| Outer Diameter | 2.8 Millimeter |
| Length | 300 Millimeter |
| Outer Diameter | 2.8 Millimeter |
| Length | 300 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10811998030255 [Unit of Use] |
| GS1 | 20811998030252 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[20811998030252]
Moist Heat or Steam Sterilization
[20811998030252]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-31 |
| Device Publish Date | 2018-07-31 |
| 20811998035394 | WASHER 7MM - TITANIUM |
| 20811998032270 | GUIDEPIN 2.5MM X 230MM |
| 20811998030269 | GUIDEPIN 2.8MM X 450MM |
| 20811998030252 | GUIDEPIN 2.8MM X 300MM |
| 20811998030245 | WASHER 13MM |
| 20811998030238 | GUIDEPIN 1.25MM X 150MM |
| 20811998030221 | WASHER 7MM |
| M69601SHS160 | LAG SCREW RETAINING ROD (FOR INSERTION) |
| M69601SHS150 | GUIDESHAFT W/FLATS |
| M69601SHS010 | LAG SCREW RETAINING ROD (FOR REMOVAL) |
| 10811998032211 | LAG SCREW RETAINING ROD (FOR INSERTION) |
| 10811998032204 | GUIDESHAFT W/FLATS |
| 10811998032068 | LAG SCREW RETAINING ROD (FOR REMOVAL) |
| M69601SHS200 | 130 DEG ANGLE GUIDE |
| M69601SHS070 | 145 DEG ANGLE GUIDE |
| M69601SHS060 | 140 DEG ANGLE GUIDE |
| M69601SHS050 | 135 DEG ANGLE GUIDE |
| M69601SHS040 | DRILL GUIDE 3.2MM/4.5MM (HIP SCREW) |
| M6960173040 | 2.8MM ADJ PIN GUIDE |
| M6960140050 | DRILL GUIDE 1.25MM/2.7MM DBL SIDED |
| 10811998032259 | 130 DEG ANGLE GUIDE |
| 10811998032129 | 145 DEG ANGLE GUIDE |
| 10811998032112 | 140 DEG ANGLE GUIDE |
| 10811998032105 | 135 DEG ANGLE GUIDE |
| 10811998032099 | DRILL GUIDE 3.2MM/4.5MM (HIP SCREW) |
| 10811998030125 | 2.8MM ADJ PIN GUIDE |
| 10811998030064 | DRILL GUIDE 1.25MM/2.7MM DBL SIDED |
| M69601SHS190 | TRIPLE REAMER LOCK NUT |
| M69601SHS180 | DEPTH GAUGE FOR SHS |
| M69601SHS170 | TRIPLE REAMER SHAFT |
| M69601SHS090 | STD REAMER HEAD |
| M69601SHS080 | SHORT REAMER HEAD |
| M6960173110 | SCREW FORCEPS |
| 10811998032242 | TRIPLE REAMER LOCK NUT |
| 10811998032235 | DEPTH GAUGE FOR SHS |
| 10811998032228 | TRIPLE REAMER SHAFT |
| 10811998032143 | STD REAMER HEAD |
| 10811998032136 | SHORT REAMER HEAD |
| 10811998030194 | SCREW FORCEPS |
| 10811998039500 | WASHER 7MM - TITANIUM (10 PACK) |
| 10811998031566 | 2.8MM X 450MM DRILL TIP GUIDEPIN (10 PACK) |
| 10811998031559 | 2.8MM X 300MM DRILL TIP GUIDEPIN (10 PACK) |
| M6964001010 | STERILIZATION CASE 4.0MM CANN SCREW CADDY |
| M6964001000 | STERILIZATION CASE 4.0MM CANN SCREW SET |
| M6960401030 | STERILIZATION CASE 4.0MM CANN SCREW SET |
| M69601SHS0240 | SHS SCREW CADDY |
| M69601SHS0230 | SHS IMPLANT CASE LID |
| M69601SHS0220 | SHS IMPLANT CASE |
| M69601SHS0210 | SHS INSTRUMENT CASE LID |
| M69601SHS0200 | SHS INSTRUMENT CASE |