TiMesh
GUDID 00643169620599
PLATE 015-275 OHATA QUADSTAR BH 8.4MM OD
MEDTRONIC PS MEDICAL, INC.
Craniofacial fixation plate, non-bioabsorbable| Primary Device ID | 00643169620599 |
| NIH Device Record Key | 995e7a74-77f6-4ca1-9849-8dfb4938a012 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TiMesh |
| Version Model Number | 015-275 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169620599 [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 |
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
Moist Heat or Steam Sterilization
[00643169620599]
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 | 2016-06-18 |
On-Brand Devices [TiMesh]
| 00643169620766 | FLEXMESH 8002233-6 2.2 LARGE RIGID |
| 00643169620759 | FLEXMESH 8001533-6 1.5 LARGE RIGID |
| 00643169620742 | FLEXMESH 8001531-6 148X148MM 0.6MM CP1 |
| 00643169620735 | FLEXMESH 8001523-6 1.5 MEDIUM RIGID |
| 00643169620728 | FLEXMESH 8001521-6 1.5 MEDIUM STANDARD |
| 00643169620704 | FLEXMESH 8001511-6 1.5 SML STANDARD |
| 00643169620698 | FLEXMESH 8001511-3 1.5 SML THIN |
| 00643169620681 | STRAP 241-02 FLUSHMESH 2H X 121MM |
| 00643169620674 | PANEL 235 128MM X 79MM X .025 |
| 00643169620667 | PANEL 090 CRANIAL 152MM X 152MM |
| 00643169620650 | PANEL 016-200 CRANIAL MESH 200 X 200MM |
| 00643169620643 | PANEL 016-152 CRANIAL MESH 152 X 152MM |
| 00643169620636 | PANEL 016-128 CRANIAL MESH 128 X 79MM |
| 00643169620629 | PANEL 016-120 CRANIAL MESH 120 X 120MM |
| 00643169620612 | PANEL 016-100 CRANIAL MESH 100 X 100MM |
| 00643169620605 | PLATE 015-276 OHATA QUADSTAR BH 10MM OD |
| 00643169620599 | PLATE 015-275 OHATA QUADSTAR BH 8.4MM OD |
| 00643169620582 | PLATE 015-273 OHATA KERF COVER |
| 00643169620575 | TRISTAR 015-270 OHATA BURR 8.4MM OD |
| 00643169620568 | BLADE 015-262-18 FAN BURR HOLE 18MM DIA |
| 00643169620551 | BLADE 015-262-14 FAN BURR HOLE 14MM DIA |
| 00643169620544 | BLADE 015-262-11 FAN BURR HOLE 11MM DIA |
| 00643169620537 | MESH 015-260-18 BURR HOLE 18MM DIA |
| 00643169620520 | MESH 015-260-14 BURR HOLE 14MM DIA |
| 00643169620513 | MESH 015-260-11 BURR HOLE 11MM DIAMETER |
| 00643169620506 | PLATE 015-258 SMALL RECTANGLE |
| 00643169620490 | PLATE 015-257-C SQUARE SMALL RIGID |
| 00643169620483 | PLATE 015-257 SQUARE SMALL |
| 00643169620476 | PLATE 015-255 SMALL X |
| 00643169620469 | PLATE 015-247 STRAIGHT 2H X 2H 5MM |
| 00643169620452 | PLATE 015-246 STRAIGHT 2H X 2H 2.5MM |
| 00643169620445 | PLATE 015-237 Y 3H X 3H 5MM DOUBLE |
| 00643169620438 | PLATE 015-236 Y 3H X 3H 2.5MM DOUBLE |
| 00643169620421 | PLATE 015-233 SINGLE Y 3HX3H 2.5MM 1.60W |
| 00643169620414 | PLATE 015-230 SINGLE Y 3HX3H 2.5MM 1.07W |
| 00643169620407 | ISOGRID 015-2050 STANDARD 75MM X 75MM |
| 00643169620391 | GRIDMESH 015-2010 SQUARE-RECTANGULAR |
| 00643169620384 | GRID 015-2001-5-C RIGID 11 X 7.5CM 5MM |
| 00643169620377 | GRIDMESH 015-2001-5 11CM X 7.5CM 5MM HCD |
| 00643169620360 | GRID 015-2001-4-C RIGID 11 X 7.5CM 4MM |
| 00643169620353 | GRIDMESH 015-2001-4 11CM X 7.5CM 4MM HCD |
| 00643169620346 | PLATE 015-160 H 3H X 1H X 3H |
| 00643169620339 | PLATE 015-130 T 3H X 3H |
| 00643169620322 | PLATE 015-102R RIGHT L 2H X 5H |
| 00643169620315 | PLATE 015-090 CURVED 12H |
| 00643169620308 | PLATE 015-044-C RIGID STRT 1H X 1H 12MM |
| 00643169620292 | PLATE 015-044 STRAIGHT 1H X 1H 12MM |
| 00643169620285 | PLATE 015-042-C RIGID STRT 1H X 1H 8MM |
| 00643169620278 | PLATE 015-042 STRAIGHT 1H X 1H 8MM |
| 00643169620261 | PLATE 015-040-C RIGID STRT 1H X 1H 4MM |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.