| Primary Device ID | 00810030820734 | 
| NIH Device Record Key | 777dbcaa-9c37-49ef-855f-5c7a6a7da017 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Cannulated Compression Headless Screw | 
| Version Model Number | 1ZB50246 | 
| Catalog Number | 1ZB50246 | 
| Company DUNS | 010968002 | 
| Company Name | Tyber Medical LLC | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | MR Conditional | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | true | 
| 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 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 | 
| jstigliano@tybermed.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00810030820734 [Primary] | 
| HWC | Screw, fixation, bone | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
[00810030820734]
Moist Heat or Steam Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2020-02-11 | 
| Device Publish Date | 2020-01-11 | 
| 00819917027075 | 9.0MM/2.8MM GUIDE WIRE SLEEVE | 
| 00819917027051 | 11.0MM/9.0MM TISSUE PROTECTOR | 
| 00819917027044 | 7.5MM/1.6MM GUIDE WIRE SLEEVE | 
| 00819917027020 | 9.5 MM/7.5MM TISSUE PROTECTOR | 
| 00819917027013 | CANN SCRWDRVR HANDLE WITH RATCHET LG QUICK COUPLING | 
| 00819917027006 | CANN SCRWDRVR HANDLE WITH RATCHET QUICK COUPLING | 
| 00819917026993 | CANN SCRWDRVR HANDLE WITH JWLRS CAP QUICK COUPLING | 
| 00819917026986 | DIRECT MEASURING DEVICE FOR 220MM WIRE | 
| 00819917026979 | DIRECT MEASURING DEVICE FOR 150MM WIRE | 
| 00819917026962 | DIRECT MEASURING DEVICE FOR 100MM WIRE | 
| 00819917026955 | 5.0MM/2.8MM DOUBLE DRILL GUIDE | 
| 00819917026948 | 3.0MM/1.6MM DOUBLE DRILL GUIDE | 
| 00819917026931 | 2.7MM/1.4MM DOUBLE DRILL GUIDE | 
| 00819917026924 | 2.0MM/1.1MM DOUBLE DRILL GUIDE | 
| 00819917026917 | 1.6MM/0.8MM DOUBLE DRILL GUIDE | 
| 00819917026900 | T30 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN | 
| 00819917026894 | T15 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN | 
| 00819917026887 | T8 STRDRV SCRWDRVR SHAFT SLF-RETAIN | 
| 00819917026870 | T8 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN | 
| 00819917026863 | T6 STRDRV SCRWDRVR SHAFT SLF-RETAIN | 
| 00819917026856 | T6 CANN STRDRV SCRWDRVR SHAFT SLF-RETAIN | 
| 00819917026696 | CANN COUNTERSINK FOR 6.5MM/7.5MM CANN HEADLESS SCREW/LARGE QC | 
| 00819917026689 | CANN COUNTERSINK FOR 4.5MM/5.5MM CANN HEADLESS SCREW/QC | 
| 00819917026672 | CANN COUNTERSINK FOR 3.5MM/4.0MM CANN HEADLESS SCREW/QC | 
| 00819917026665 | CANN COUNTERSINK FOR 2.5MM/3.0MM CANN HEADLESS SCREW/QC | 
| 00819917026658 | CANN COUNTERSINK FOR 2.0MM CANN HEADLESS SCREW/QC | 
| 00819917026597 | 5.0MM CANN DRILL BIT LARGE QC/ 215MM | 
| 00819917026580 | 3.0MM CANN DRILL BIT QC/ 215MM | 
| 00819917026573 | 2.7MM CANN DRILL BIT QC/ 145MM | 
| 00819917026566 | 2.0MM CANN DRILL BIT QC/ 145MM | 
| 00819917026559 | 1.6MM CANN DRILL BIT QC/ 95MM | 
| 00819917026481 | 2.8MM GUIDE WIRE/ 300MM LENGTH FLUTED TIP | 
| 00819917026474 | 2.8MM GUIDE WIRE/ 220MM LENGTH FLUTED TIP | 
| 00819917026467 | 1.6MM GUIDE WIRE/ 220MM LENGTH TROCAR TIP | 
| 00819917026450 | 1.4MM GUIDE WIRE / 150MM LENGTH TROCAR TIP | 
| 00819917026443 | 1.1MM GUIDE WIRE/ 150MM LENGTH TROCAR TIP | 
| 00819917026436 | 0.8MM GUIDE WIRE/ 100MM LENGTH TROCAR TIP | 
| 00819917026429 | 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 140MM | 
| 00819917026412 | 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 135MM | 
| 00819917026405 | 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 130MM | 
| 00819917026399 | 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 125MM | 
| 00819917026382 | 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 120MM | 
| 00819917026375 | 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 115MM | 
| 00819917026368 | 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 110MM | 
| 00819917026351 | 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 105MM | 
| 00819917026344 | 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 100MM | 
| 00819917026337 | 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 95MM | 
| 00819917026320 | 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 90MM | 
| 00819917026313 | 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 85MM | 
| 00819917026306 | 7.5MM TI CANN COMPRESSION HEADLESS SCREW- LT- 80MM |