| Primary Device ID | 00196449024544 |
| NIH Device Record Key | 7445cf9d-92ef-42fa-ad05-f9710467627c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cannulated Headless Screw - Full Thread |
| Version Model Number | 03.333.917 |
| Company DUNS | 010968002 |
| Company Name | Tyber Medical, 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(866)761-0933 |
| ra@tybermed.com | |
| Phone | +1(866)761-0933 |
| ra@tybermed.com | |
| Phone | +1(866)761-0933 |
| ra@tybermed.com | |
| Phone | +1(866)761-0933 |
| ra@tybermed.com | |
| Phone | +1(866)761-0933 |
| ra@tybermed.com | |
| Phone | +1(866)761-0933 |
| ra@tybermed.com | |
| Phone | +1(866)761-0933 |
| ra@tybermed.com | |
| Phone | +1(866)761-0933 |
| ra@tybermed.com | |
| Phone | +1(866)761-0933 |
| ra@tybermed.com | |
| Phone | +1(866)761-0933 |
| ra@tybermed.com | |
| Phone | +1(866)761-0933 |
| ra@tybermed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00196449024544 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00196449024544]
Moist Heat or Steam Sterilization
[00196449024544]
Moist Heat or Steam Sterilization
[00196449024544]
Moist Heat or Steam Sterilization
[00196449024544]
Moist Heat or Steam Sterilization
[00196449024544]
Moist Heat or Steam Sterilization
[00196449024544]
Moist Heat or Steam Sterilization
[00196449024544]
Moist Heat or Steam Sterilization
[00196449024544]
Moist Heat or Steam Sterilization
[00196449024544]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-08-15 |
| Device Publish Date | 2025-07-24 |
| 00196449033416 | 2/3 MODULAR TRAY LID |
| 00196449033096 | OUTER CASE 3/3 LENGTH 2-HIGH WITH LID FOR CANN SCREWS |
| 00196449033089 | OUTER CASE 1/3 LENGTH 3-HIGH WITH LID FOR CANN SCREWS |
| 00196449033072 | 2.5-4.0MM INSTRUMENT TRAY FOR CANN SCREWS |
| 00196449033065 | SCREW RACK FOR 2.0-4.0MM CANN SCREWS |
| 00196449033058 | SCREW RACK FOR 4.5/6.5MM CANN SCREWS |
| 00196449033041 | SCREW TYPE MARKER PUSH PIN/LONG/FULL THREAD |
| 00196449033034 | SCREW TYPE MARKER PUSH PIN/SHORT/FULL THREAD |
| 00196449024773 | CANN CNTRSNK F/6.5/7.5MM HDED CANN SCR/LARGE QC LNG, REUSABLE STERILE |
| 00196449024766 | CANN CNTRSNK F/6.5/7.5MM HDED CANN SCR/LARGE QC LNG, REUSABLE |
| 00196449024759 | CANN CNTRSNK F/6.5/7.5MM HDED CANN SCR/LARGE QC, REUSABLE STERILE |
| 00196449024742 | CANN CNTRSNK F/6.5/7.5MM HDED CANN SCR/LARGE QC, REUSABLE |
| 00196449024735 | CANN CNTRSNK F/4.5/5.5MM HDED CANNULATED SCREW QC, REUSABLE STERILE |
| 00196449024728 | CANN CNTRSNK F/4.5/5.5MM HDED CANNULATED SCREW QC, REUSABLE |
| 00196449024711 | CANN CNTRSNK F/3.5/4.0MM HDED CANNULATED SCREW QC, REUSABLE STERILE |
| 00196449024704 | CANN CNTRSNK F/3.5/4.0MM HDED CANNULATED SCREW QC, REUSABLE |
| 00196449024698 | CANN CNTRSNK F/2.5/3.0MM HDED CANNULATED SCREW QC, REUSABLE STERILE |
| 00196449024681 | CANN CNTRSNK F/2.5/3.0MM HDED CANNULATED SCREW QC, REUSABLE |
| 00196449024674 | CANN CNTRSNK F/2.0MM HEADED CANNULATED SCREW QC, REUSABLE STERILE |
| 00196449024667 | CANN CNTRSNK F/2.0MM HEADED CANNULATED SCREW QC, REUSABLE |
| 00196449024650 | CANN COUNTERSINK F/6.5/7.5MM LNG CCHS SCREW QC, REUSABLE STERILE |
| 00196449024643 | CANN COUNTERSINK F/6.5/7.5MM LNG CCHS SCREW QC, REUSABLE |
| 00196449024636 | CANN COUNTERSINK F/6.5/7.5MM CCHS SCREW QC, REUSABLE STERILE |
| 00196449024629 | CANN COUNTERSINK F/6.5/7.5MM CCHS SCREW QC, REUSABLE |
| 00196449024612 | CANN COUNTERSINK F/4.5/5.5MM CCHS SCREW QC, REUSABLE STERILE |
| 00196449024605 | CANN COUNTERSINK F/4.5/5.5MM CCHS SCREW QC, REUSABLE |
| 00196449024599 | CANN COUNTERSINK F/3.5/4.0MM CCHS SCREW QC, REUSABLE STERILE |
| 00196449024582 | CANN COUNTERSINK F/3.5/4.0MM CCHS SCREW QC, REUSABLE |
| 00196449024575 | CANN COUNTERSINK F/2.5/3.0MM CCHS SCREW QC, REUSABLE STERILE |
| 00196449024568 | CANN COUNTERSINK F/2.5/3.0MM CCHS SCREW QC, REUSABLE |
| 00196449024551 | CANN COUNTERSINK FOR 2.0MM CCHS SCREW QC, REUSABLE STERILE |
| 00196449024544 | CANN COUNTERSINK FOR 2.0MM CCHS SCREW QC, REUSABLE |
| 00196449024537 | 7.5MM CANN DRILL BIT LARGE QC/LONG, REUSABLE STERILE |
| 00196449024520 | 7.5MM CANN DRILL BIT LARGE QC/LONG, REUSABLE |
| 00196449024513 | 5.0MM CANN DRILL BIT LARGE QC/LONG, REUSABLE STERILE |
| 00196449024506 | 5.0MM CANN DRILL BIT LARGE QC/LONG, REUSABLE |
| 00196449024490 | 5.0MM CANN DRILL BIT LARGE QC/215MM, REUSABLE STERILE |
| 00196449024483 | 5.0MM CANN DRILL BIT LARGE QC/215MM, REUSABLE |
| 00196449024476 | 3.0MM CANN DRILL BIT QC/215MM, REUSABLE STERILE |
| 00196449024469 | 3.0MM CANN DRILL BIT QC/215MM, REUSABLE |
| 00196449024452 | 2.7MM CANN DRILL BIT QC/145MM, REUSABLE STERILE |
| 00196449024445 | 2.7MM CANN DRILL BIT QC/145MM, REUSABLE |
| 00196449024438 | 2.0MM CANN DRILL BIT QC/145MM, REUSABLE STERILE |
| 00196449024421 | 2.0MM CANN DRILL BIT QC/145MM, REUSABLE |
| 00196449024414 | 1.6MM CANN DRILL BIT QC/95MM, REUSABLE STERILE |
| 00196449024407 | 1.6MM CANN DRILL BIT QC/95MM, REUSABLE |
| 00196449024391 | O'BRIEN BONE CLAMP/SMALL |
| 00196449024384 | O'BRIEN BONE CLAMP/EXTRA SMALL |
| 00196449024377 | COMPRESSOR/SMALL |
| 00196449024360 | COMPRESSOR/EXTRA SMALL |