| Primary Device ID | 00840606154680 | 
| NIH Device Record Key | 1e971190-cedf-4527-8bed-c80f33659894 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Overwatch | 
| Version Model Number | 108-006 | 
| Company DUNS | 610712213 | 
| Company Name | SPINAL ELEMENTS, INC. | 
| 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 | 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00840606154680 [Primary] | 
| LXH | Orthopedic Manual Surgical Instrument | 
| OJH | Orthopedic Tray | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
[00840606154680]
Moist Heat or Steam Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2019-10-04 | 
| Device Publish Date | 2019-09-04 | 
| 00840606154895 | MIS SET SCREW CADDY LID | 
| 00840606154888 | MIS SET SCREW CADDY BASE | 
| 00840606154871 | MIS SET SCREW CADDY | 
| 00840606154864 | 8.5 EXTENDED TAB SCREW CADDY | 
| 00840606154857 | 7.5 EXTENDED TAB SCREW CADDY | 
| 00840606154840 | 6.5 EXTENDED TAB SCREW CADDY | 
| 00840606154833 | 5.5 EXTENDED TAB SCREW CADDY | 
| 00840606154826 | OVERWATCH® MIS IMPLANT TRAY INSERT 2 | 
| 00840606154819 | OVERWATCH® MIS IMPLANT TRAY INSERT 1 | 
| 00840606154802 | OVERWATCH® MIS IMPLANT TRAY LID | 
| 00840606154796 | OVERWATCH® MIS IMPLANT TRAY BASE | 
| 00840606154789 | OVERWATCH® MIS IMPLANT TRAY | 
| 00840606154772 | OVERWATCH® MIS INSTRUMENT TRAY INSERT 2 | 
| 00840606154765 | OVERWATCH® MIS INSTRUMENT TRAY INSERT 1 | 
| 00840606154758 | OVERWATCH® MIS INSTRUMENT TRAY 2 LID | 
| 00840606154741 | OVERWATCH® MIS INSTRUMENT TRAY 2 BASE | 
| 00840606154734 | OVERWATCH® MIS INSTRUMENT TRAY 2 | 
| 00840606154727 | OVERWATCH® MIS INSTRUMENT TRAY 1 INSERT 2 | 
| 00840606154710 | OVERWATCH® MIS INSTRUMENT TRAY 1 INSERT 1 | 
| 00840606154703 | OVERWATCH® MIS INSTRUMENT TRAY I LID | 
| 00840606154697 | OVERWATCH® MISINSTRUMENT TRAY I BASE | 
| 00840606154680 | OVERWATCH® MIS INSTRUMENT TRAY I | 
| 00840606157223 | 1.4MM X 28IN NITINOL K-WIRE THREADED TROCAR TIP | 
| 00840606157216 | 1.4MM X 26IN NITINOL K-WIRE THREADED TROCAR TIP | 
| 00840606157209 | 1.4MM X 24IN NITINOL K-WIRE THREADED TROCAR TIP | 
| 00840606157193 | 1.4MM X 18IN NITINOL K-WIRE THREADED TROCAR TIP | 
| 00840606157186 | 1.4MM X 28IN NITINOL K-WIRE TROCAR TIP | 
| 00840606157179 | 1.4MM X 26IN NITINOL K-WIRE TROCAR TIP | 
| 00840606157162 | 1.4MM X 24IN NITINOL K-WIRE TROCAR TIP | 
| 00840606157155 | 1.4MM X 18IN NITINOL K-WIRE TROCAR TIP | 
| 00840606157148 | 1.4MM X 28IN NITINOL K-WIRE THREADED BLUNT TIP | 
| 00840606157131 | 1.4MM X 26IN NITINOL K-WIRE THREADED BLUNT TIP | 
| 00840606157124 | 1.4MM X 24IN NITINOL K-WIRE THREADED BLUNT TIP | 
| 00840606157117 | 1.4MM X 18IN NITINOL K-WIRE THREADED BLUNT TIP | 
| 00840606157100 | 1.4MM X 28IN NITINOL K-WIRE BLUNT TIP | 
| 00840606157094 | 1.4MM X 26IN NITINOL K-WIRE BLUNT TIP | 
| 00840606157087 | 1.4MM X 24IN NITINOL K-WIRE BLUNT TIP | 
| 00840606157070 | 1.4MM X 18IN NITINOL K-WIRE BLUNT TIP | 
| 00840606155366 | OVERWATCH® ROD-TO-ROD CONNECTOR CADDY LID | 
| 00840606155359 | OVERWATCH® ROD-TO-ROD CONNECTOR CADDY BASE | 
| 00840606155342 | OVERWATCH® ROD-TO-ROD CONNECTOR CADDY | 
| 00840606155335 | OVERWATCH® OFFSET CONNECTOR CADDY LID | 
| 00840606155328 | OVERWATCH® OFFSET CONNECTOR CADDY BASE | 
| 00840606155311 | OVERWATCH® OFFSET CONNECTOR CADDY | 
| 00840606155304 | OVERWATCH® ILIAC SCREW CADDY 2 LID | 
| 00840606155298 | OVERWATCH® ILIAC SCREW CADDY 2 BASE | 
| 00840606155281 | OVERWATCH® ILIAC SCREW CADDY 2 | 
| 00840606155274 | OVERWATCH® ILIAC SCREW CADDY 1 LID | 
| 00840606155267 | OVERWATCH® ILIAC SCREW CADDY 1 BASE | 
| 00840606155250 | OVERWATCH® ILIAC SCREW CADDY 1 |