| Primary Device ID | 00840916134792 |
| NIH Device Record Key | e98ffc1c-07a4-498d-b13a-0e8fb0484785 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Overwatch |
| Version Model Number | 108-107-03 |
| Company DUNS | 004022104 |
| Company Name | SPINAL ELEMENTS |
| 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 | 00840916134792 [Primary] |
| HXX | Screwdriver |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
[00840916134792]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-07-18 |
| Device Publish Date | 2019-05-14 |
| 00840916134686 | Quick Lock Screw Driver, Short Inner Shaft |
| 00840916134822 | Clip On Reducer Sleeve |
| 00840916134792 | Quick Lock Screw Driver, Handle |
| 00840916134693 | QUICK LOCK SCREW DRIVER OUTER SLEEVE SHORT |
| 00840916131821 | OVERWATCH® 5.5MM x 50MM MIS POLY EXTENDED TAB CANNULATED SCREW |
| 00840916131777 | Overwatch 7.5MM x 55MM Dualfix Cannulated Screw Assy, Low Top |
| 00840916131739 | Overwatch 7.5MM x 35MM Dualfix Cannulated Screw Assy, Low Top |
| 00840916131654 | Overwatch 8.5MM x 70MM Dualfix Screw Assy, Low Top |
| 00840916131630 | Overwatch 8.5MM x 60MM Dualfix Screw Assy, Low Top |
| 00840916131623 | Overwatch 8.5MM x 55MM Dualfix Screw Assy, Low Top |
| 00840916131449 | Overwatch 7.5MM x 55MM Cannulated Screw Assy, Low Top |
| 00840916131272 | Rev Conn Open Closed SBS |
| 00840916131265 | Rev Conn Closed SBS |
| 00840916131258 | Rev Conn End To End |
| 00840916131241 | Rev Conn SBS Open |
| 00840916131180 | 190MM Overwatch MIS Rod |
| 00840916131104 | 130MM Overwatch MIS Rod |
| 00840916131098 | 125MM Overwatch MIS Rod |
| 00840916131043 | 100MM Overwatch MIS Rod |
| 00840916131012 | 85MM Overwatch MIS Rod |
| 00840916130978 | 65MM Overwatch MIS Rod |
| 00840916130961 | 60MM Overwatch MIS Rod |
| 00840916130954 | 55MM Overwatch MIS Rod |
| 00840916130923 | 40MM Overwatch MIS Rod |
| 00840916130480 | Overwatch 9.5MM x 35MM Low Top Pedicle Screw |
| 00840916130473 | Overwatch 9.5MM x 30MM Low Top Pedicle Screw |
| 00840916130466 | Overwatch 9.5MM x 25MM Low Top Pedicle Screw |
| 00840916130459 | Overwatch 9.5MM x 110MM Low Top Pedicle Screw |
| 00840916130442 | Overwatch 9.5MM x 105MM Low Top Pedicle Screw |
| 00840916130435 | Overwatch 9.5MM x 100MM Low Top Pedicle Screw |
| 00840916130411 | Overwatch 8.5MM x 90MM Low Top Pedicle Screw |
| 00840916130404 | Overwatch 8.5MM x 85MM Low Top Pedicle Screw |
| 00840916130381 | Overwatch 8.5MM x 75MM Low Top Pedicle Screw |
| 00840916130374 | Overwatch 8.5MM x 70MM Low Top Pedicle Screw |
| 00840916130367 | Overwatch 8.5MM x 65MM Low Top Pedicle Screw |
| 00840916130343 | Overwatch 8.5MM x 55MM Low Top Pedicle Screw |
| 00840916130190 | Overwatch 7.5MM x 70MM Low Top Pedicle Screw |
| 00840916130183 | Overwatch 7.5MM x 65MM Low Top Pedicle Screw |
| 00840916130138 | Overwatch 7.5MM x 40MM Low Top Pedicle Screw |
| 00840916132712 | Overwatch 7.5MM x 45MM Dualfix Reduction Screw |
| 00840916132569 | Overwatch 9.5MM x 90MM Sagittal Reduction Screw |
| 00840916132552 | Overwatch 9.5MM x 85MM Sagittal Reduction Screw |
| 00840916132064 | OVERWATCH® 7.5MM x 55MM MIS POLY EXTENDED TAB CANNULATED SCREW |
| 00840916132057 | OVERWATCH® 7.5MM x 50MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW |
| 00840916132040 | OVERWATCH® 7.5MM x 45MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW |
| 00840916132026 | OVERWATCH® 7.5MM x 35MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW |
| 00840916132019 | OVERWATCH® 6.5MM x 55MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW |
| 00840916132002 | OVERWATCH® 6.5MM x 50MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW |
| 00840916131999 | OVERWATCH® 6.5MM x 45MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW |
| 00840916131982 | OVERWATCH® 6.5MM x 40MM MIS POLY EXTENDED TAB DUALFIX CANNULATED SCREW |