Primary Device ID | 00840606155267 |
NIH Device Record Key | a0c4af32-bf86-4c94-9795-6201828a2528 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Overwatch |
Version Model Number | 108-845-01 |
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 | 00840606155267 [Primary] |
OJH | Orthopedic Tray |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
[00840606155267]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-10-23 |
Device Publish Date | 2019-10-15 |
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 |