TiMesh®

GUDID 00681490904360

DRIVER 8001201 HANDL MOD TIMESH

MEDTRONIC PS MEDICAL, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00681490904360
• NIH Device Record Key: 04b39f31-ae38-429d-a125-696e049c6d79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiMesh®
• Version Model Number: 8001201
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, 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

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490904360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062348

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00681490904360]

Moist Heat or Steam Sterilization

[00681490904360]

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: 2015-07-01

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