SOVEREIGN™ Spinal System
GUDID 00613994550828
LID 7960068 SCREW CADDY
MEDTRONIC SOFAMOR DANEK, INC.
Instrument tray, reusable| Primary Device ID | 00613994550828 |
| NIH Device Record Key | 358d5ae1-2823-415b-8705-40ea5fd492a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOVEREIGN™ Spinal System |
| Version Model Number | 7960068 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| 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 | false |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994550828 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190840
FDA Product Code
| FSM | TRAY, SURGICAL, INSTRUMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
[00613994550828]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-12 |
| Device Publish Date | 2021-03-04 |
On-Brand Devices [SOVEREIGN™ Spinal System]
| 00613994736611 | SCREW 7975520 SOVEREIGN FA 5.5 X 20MM |
| 00613994736598 | SCREW 7975525 SOVEREIGN FA 5.5 X 25MM |
| 00613994736574 | SCREW 7975530 SOVEREIGN FA 5.5 X 30MM |
| 00613994736550 | SCREW 7975535 SOVEREIGN FA 5.5 X 35MM |
| 00613994736536 | SCREW 7976020 SOVEREIGN FA 6.0 X 20MM |
| 00613994736512 | SCREW 7976025 SOVEREIGN FA 6.0 X 25MM |
| 00613994736499 | SCREW 7976030 SOVEREIGN FA 6.0 X 30MM |
| 00613994736475 | SCREW 7976035 SOVEREIGN FA 6.0 X 35MM |
| 00613994545329 | SHAFT 7967081 L INSERTER |
| 00613994545312 | SHAFT 7967080 M INSERTER |
| 00613994545305 | SHAFT 7967079 S INSERTER |
| 00613994513489 | SCREW Y7966030 6.0 X 30MM SELF-TAP |
| 00613994513472 | SCREW Y7966025 6.0 X 25MM SELF-TAP |
| 00613994513458 | SCREW Y7965525 5.5 X 25MM SELF-TAP |
| 00613994504234 | SPACER Y7968816 M 37X27X 16MM, 8 DEG |
| 00613994504227 | SPACER Y7968814 M 37X27X 14MM, 8 DEG |
| 00613994504210 | SPACER Y7968812 M 37X27X 12MM, 8 DEG |
| 00613994504203 | COVERPLATE Y7968330 MEDIUM |
| 00613994504197 | SPACER Y7967816 S 32X23X 16MM, 8 DEG |
| 00613994504180 | SPACER Y7967814 S 32X23X 14MM, 8 DEG |
| 00613994504173 | SPACER Y7967812 S 32X23X 12MM, 8 DEG |
| 00613994504166 | COVERPLATE Y7967330 SMALL |
| 00613994501929 | SCREW 7966035 6.0MM X 35MM SELF TAP |
| 00613994501912 | SCREW 7966030 6.0MM X 30MM SELF TAP |
| 00613994501905 | SCREW 7966025 6.0MM X 25MM SELF TAP |
| 00613994501899 | SCREW 7966020 6.0MM X 20MM SELF TAP |
| 00613994501875 | SCREW 7965535 5.5MM X 35MM SELF TAP |
| 00613994501868 | SCREW 7965530 5.5MM X 30MM SELF TAP |
| 00613994501851 | SCREW 7965525 5.5MM X 25MM SELF TAP |
| 00613994501844 | SCREW 7965520 5.5MM X 20MM SELF TAP |
| 00613994501004 | ASSEMBLY 7967210 S 32X23 10MM 12DEG CP |
| 00613994500991 | ASSEMBLY 7967212 S 32X23 12MM 12DEG CP |
| 00613994500984 | ASSEMBLY 7967214 S 32X23 14MM 12DEG CP |
| 00613994500977 | SPACER 7967216 S 32 X 23 X16MM 12 DEG |
| 00613994500960 | ASSEMBLY 7967218 S 32X23 18MM 12DEG CP |
| 00613994500953 | SPACER 7967220 S 32 X 23 X20MM 12 DEG |
| 00613994500946 | ASSEMBLY 7967222 S 32X23 22MM 12DEG CP |
| 00613994500939 | SPACER 7967224 S 32 X 23 X24MM 12 DEG |
| 00613994500922 | SPACER 7967810 S 32 X 23 X10MM 8 DEG |
| 00613994500915 | ASSEMBLY 7967812 S 32X23 12MM 8DEG CP |
| 00613994500908 | SPACER 7967814 S 32 X 23 X14MM 8 DEG |
| 00613994500892 | ASSEMBLY 7967816 S 32X23 16MM 8DEG CP |
| 00613994500885 | ASSEMBLY 7967818 S 32X23 18MM 8DEG CP |
| 00613994500878 | ASSEMBLY 7967820 S 32X23 20MM 8DEG CP |
| 00613994500861 | ASSEMBLY 7967822 S 32X23 22MM 8DEG CP |
| 00613994500854 | SPACER 7967824 S 32 X 23 X24MM 8 DEG |
| 00613994321176 | SHAFT 7967007 S INSERTER |
| 00613994321169 | SHAFT 7967008 M INSERTER |
| 00613994321152 | SHAFT 7967009 L INSERTER |
| 00613994321121 | INSERTER 7967012 CP |
Trademark Results [SOVEREIGN]
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