| Primary Device ID | 00819917026917 |
| NIH Device Record Key | c5b7e2d1-fff3-4426-92c1-562ab7e31523 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cannulated Compression Headless Screw |
| Version Model Number | 03.333.400 |
| Catalog Number | 03.333.400 |
| Company DUNS | 010968002 |
| Company Name | Tyber Medical 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 | false |
| 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 | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com | |
| Phone | +1(866)761-0933 |
| ksimpkins@tybermed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819917026917 [Primary] |
| FZX | Guide, surgical, instrument |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
[00819917026917]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-09-20 |
| Device Publish Date | 2019-06-13 |
| 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 |