TiMesh®
GUDID 00673978002675
PLATE 015-042-C RIGID STRT 1H X 1H 8MM
MEDTRONIC PS MEDICAL, INC.
Craniofacial fixation plate, non-bioabsorbable| Primary Device ID | 00673978002675 |
| NIH Device Record Key | 5fb68661-ee8e-4bda-9c5b-deda3ccf4faa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TiMesh® |
| Version Model Number | 015-042-C |
| Company DUNS | 089055867 |
| Company Name | MEDTRONIC PS MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 Dimensions
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
| Length | 8 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00673978002675 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K062348
FDA Product Code
| HRS | PLATE, FIXATION, BONE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
[00673978002675]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-06-29 |
On-Brand Devices [TiMesh®]
| 00613994840301 | BATTERY 8004101 BPD SINGLE |
| 20613994471561 | SCREW 8001850 RESCUE 1.8 X 5.0 6PK |
| 20613994471523 | SCREW 805 2.2MM X-DRV 5MM 6PK |
| 20613994471516 | SCREW 804 2.2MM X-DRV 4MM 6PK |
| 00613994284655 | PANEL 016-200 CRANIAL MESH 200 X 200MM |
| 00613994284648 | PANEL 016-152 CRANIAL MESH 152 X 152MM |
| 00613994284631 | PANEL 016-128 CRANIAL MESH 128 X 79MM |
| 00613994284624 | PANEL 016-120 CRANIAL MESH 120 X 120MM |
| 00613994284617 | PANEL 016-100 CRANIAL MESH 100 X 100MM |
| 00613994106834 | SCREW 9011640 TIMESH 1.6X4.0MM SDS OPT 1 |
| 00613994106827 | SCREW 9011635 TIMESH 1.6X3.5MM SDS OPT 1 |
| 20613994106814 | SCREW 9001640 TIMESH SDS 1.6X4.0MM OPT 6 |
| 20613994106807 | SCREW 9001635 TIMESH SDS 1.6X3.5MM OPT 6 |
| 00643169620711 | FLEXMESH 8001521-3 1.5 MEDIUM THIN |
| 00643169590311 | BIT 015-1306 DRILL 1.3MM X 6MM |
| 00643169590304 | BIT 015-1304 DRILL HALL 1.3MM X 4MM |
| 00643169582934 | TRAY 8004200 BATTERY POWERED DRIVER |
| 00643169497931 | CADDY 8001605 CRANI FIX SCRW 1.6MM SD |
| 00643169497924 | BASE 8009000 TRAY CRANI FIX 1.5/1.6MM |
| 00643169497917 | CADDY 8009002 PLATE CRANI FIX 1.5/1.6MM |
| 00643169497900 | LID 8009008 CRANI FIX MOD HAND |
| 00643169497870 | DRIVER 8001201 HANDL MOD TIMESH |
| 00643169497863 | DRIVER 8001205 MOD SHAFT 1.6MM |
| 00643169497856 | SCREWDRIVER 8001215 CRUCIATE MOD SHAFT |
| 00643169497849 | SCRWDRVR 8001222 2.2 CRUICAT MOD SHAFT |
| 00643169497832 | SHAFT 8001225 QUADRIVE MOD SCREWDRIVER |
| 00643169497825 | LID 8001503 TRAY CRANI FIX 1.5 MM ST |
| 00643169497818 | CADDY 8001505 SCREW CRANI FIX 1.5MM ST |
| 00643169497801 | LID 8001603 CRANI FIX TRAY 1.6MM SD |
| 00643169497764 | CUTTER 433 WIRE MODIFIED W/CARBIDE |
| 00681490991216 | SCRWDRVR 8001222 2.2 CRUICAT MOD SHAFT |
| 00681490904407 | SHAFT 8001225 QUADRIVE MOD SCREWDRIVER |
| 00681490904391 | SCREWDRIVER 8001215 CRUCIATE MOD SHAFT |
| 00681490904384 | DRIVER 8001205 MOD SHAFT 1.6MM |
| 00681490904360 | DRIVER 8001201 HANDL MOD TIMESH |
| 00673978036632 | SCREW 805 2.2MM X-DRV 5MM 6 |
| 00673978024318 | CUTTER 433 WIRE MODIFIED W/CARBIDE |
| 00673978015057 | STRAP 241-02 FLUSHMESH 2H X 121MM |
| 00673978014562 | PANEL 235 128MM X 79MM X .025 |
| 00673978004747 | PANEL 090 CRANIAL 152MM X 152MM |
| 00673978003535 | PLATE 015-276 OHATA QUADSTAR BH 10MM OD |
| 00673978003528 | PLATE 015-275 OHATA QUADSTAR BH 8.4MM OD |
| 00673978003511 | PLATE 015-273 OHATA KERF COVER |
| 00673978003498 | TRISTAR 015-270 OHATA BURR 8.4MM OD |
| 00673978003481 | BLADE 015-262-18 FAN BURR HOLE 18MM DIA |
| 00673978003474 | BLADE 015-262-14 FAN BURR HOLE 14MM DIA |
| 00673978003467 | BLADE 015-262-11 FAN BURR HOLE 11MM DIA |
| 00673978003429 | MESH 015-260-18 BURR HOLE 18MM DIA |
| 00673978003412 | MESH 015-260-14 BURR HOLE 14MM DIA |
| 00673978003405 | MESH 015-260-11 BURR HOLE 11MM DIAMETER |
Trademark Results [TiMesh]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TIMESH 75315249 2220142 Dead/Cancelled |
Sofamor Danek Properties, Inc. 1997-06-26 |
 TIMESH 75102736 2047832 Live/Registered |
MEDTRONIC, INC. 1996-05-13 |
 TIMESH 73662837 1492999 Dead/Cancelled |
TIMESH, INC. 1987-05-26 |
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