TSRH® Spinal System
GUDID 00613994803405
ROD MODULE 8359010 TSRH 3DX 2-SIDED
MEDTRONIC SOFAMOR DANEK, INC.
Instrument tray| Primary Device ID | 00613994803405 |
| NIH Device Record Key | 4942eb40-2ee5-4a32-8fa8-d1fb97b25c64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TSRH® Spinal System |
| Version Model Number | 8359010 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994803405 [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 |
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
[00613994803405]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2017-12-01 |
On-Brand Devices [TSRH® Spinal System]
| 00613994888518 | SCREW X09103822 4.5X30 MPA LONG-POST |
| 00613994888501 | SCREW X09103823 4.5X35 MPA LONG-POST |
| 00613994888495 | SCREW X09103824 4.5X40 MPA LONG-POST |
| 00613994888488 | SCREW X09103825 4.5X45 MPA LONG-POST |
| 00613994888471 | SCREW X09103826 4.5X50 MPA LONG-POST |
| 00613994888464 | SCREW X09103827 4.5X55 MPA LONG-POST |
| 00613994888457 | SCREW X09103828 4.5X60 MPA LONG-POST |
| 00613994888440 | SCREW X09103829 4.5X30 MPA SHORT-POST |
| 00613994888433 | SCREW X09103830 4.5X35 MPA SHORT-POST |
| 00613994888426 | SCREW X09103831 4.5X40 MPA SHORT-POST |
| 00613994888419 | SCREW X09103832 4.5X45 MPA SHORT-POST |
| 00613994888402 | SCREW X09103833 4.5X50 MPA SHORT-POST |
| 00613994888396 | SCREW X09103834 4.5X55 MPA SHORT-POST |
| 00613994888389 | SCREW X09103835 4.5X60 MPA SHORT-POST |
| 00613994888358 | SCREW 83565359H TSRH OSTEOGRIP HA |
| 00613994888341 | SCREW 83565309H TSRH OSTEOGRIP HA |
| 00613994888334 | SCREW 83565259H TSRH OSTEOGRIP HA |
| 00613994888327 | SCREW 83565209H TSRH OSTEOGRIP HA |
| 00613994888310 | SCREW 83555609H TSRH OSTEOGRIP HA |
| 00613994888303 | SCREW 83555559H TSRH OSTEOGRIP HA |
| 00613994888297 | SCREW 83555509H TSRH OSTEOGRIP HA |
| 00613994888280 | SCREW 83555459H TSRH OSTEOGRIP HA |
| 00613994888273 | SCREW 83555409H TSRH OSTEOGRIP HA |
| 00613994888266 | SCREW 83555359H TSRH OSTEOGRIP HA |
| 00613994888259 | SCREW 83555309H TSRH OSTEOGRIP HA |
| 00613994888242 | SCREW 83555259H TSRH OSTEOGRIP HA |
| 00613994888235 | SCREW 83555209H TSRH OSTEOGRIP HA |
| 00613994888228 | SCREW 83545609H TSRH OSTEOGRIP HA |
| 00613994888211 | SCREW 83545559H TSRH OSTEOGRIP HA |
| 00613994888204 | SCREW 83545509H TSRH OSTEOGRIP HA |
| 00613994888198 | SCREW 83545459H TSRH OSTEOGRIP HA |
| 00613994888181 | SCREW 83545409H TSRH OSTEOGRIP HA |
| 00613994888174 | SCREW 83545359H TSRH OSTEOGRIP HA |
| 00613994888167 | SCREW 83545309H TSRH OSTEOGRIP HA |
| 00613994888150 | SCREW 83545259H TSRH OSTEOGRIP HA |
| 00613994888143 | SCREW 83545209H TSRH OSTEOGRIP HA |
| 00613994888136 | SCREW 83565409H TSRH OSTEOGRIP HA |
| 00613994888129 | SCREW 83585609H TSRH OSTEOGRIP HA |
| 00613994888112 | SCREW 83585559H TSRH OSTEOGRIP HA |
| 00613994888105 | SCREW 83585509H TSRH OSTEOGRIP HA |
| 00613994888099 | SCREW 83585459H TSRH OSTEOGRIP HA |
| 00613994888082 | SCREW 83585409H TSRH OSTEOGRIP HA |
| 00613994888075 | SCREW 83585359H TSRH OSTEOGRIP HA |
| 00613994888068 | SCREW 83585309H TSRH OSTEOGRIP HA |
| 00613994888051 | SCREW 83585259H TSRH OSTEOGRIP HA |
| 00613994888044 | SCREW 83585209H TSRH OSTEOGRIP HA |
| 00613994888037 | SCREW 83575609H TSRH OSTEOGRIP HA |
| 00613994888020 | SCREW 83575559H TSRH OSTEOGRIP HA |
| 00613994888013 | SCREW 83575509H TSRH OSTEOGRIP HA |
| 00613994888006 | SCREW 83575459H TSRH OSTEOGRIP HA |
Trademark Results [TSRH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TSRH 74164314 1694200 Live/Registered |
TEXAS SCOTTISH RITE HOSPITAL FOR CRIPPLED CHILDREN 1991-05-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.