Primary Device ID | 00840916130374 |
NIH Device Record Key | 210aa7dc-bdbd-4f97-9852-764df7113832 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Overwatch |
Version Model Number | 108-L-8570 |
Company DUNS | 004022104 |
Company Name | SPINAL ELEMENTS |
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 | true |
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 | 00840916130374 [Primary] |
NKB | Thoracolumbosacral Pedicle Screw System |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
[00840916130374]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-07-18 |
Device Publish Date | 2017-07-18 |
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 |