MONARCH 177450120

GUDID 10705034062365

MONARCH SPINE SYSTEM S/C WITH WASHER, EXT 5.5mm

Medos International Sàrl

Implantable bone washer

• Primary Device ID: 10705034062365
• NIH Device Record Key: c307252f-6895-4008-95c3-36a8800237c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONARCH
• Version Model Number: 177450120
• Catalog Number: 177450120
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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: 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

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034062365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010576

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

[10705034062365]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-29
• Device Publish Date: 2024-07-19

On-Brand Devices [MONARCH]

• 10705034063102: MONARCH SPINE SYSTEM DUAL DIAMETER ROD 5.5/6.35 x 450mm
• 10705034196794: MONARCH SPINE SYSTEM MODULAR HEXLOBE DRIVER x25
• 10705034196787: MONARCH SPINE SYSTEM TORQUE WRENCH, HEXLOBE SHAFT
• 10705034196770: MONARCH SPINE SYSTEM TORQUE WRENCH-HANDLE
• 10705034196725: MONARCH SPINE SYSTEM WRENCH x25
• 10705034196688: MONARCH SPINE SYSTEM ROD TEMPLATE, LONG
• 10705034196664: MONARCH SPINE SYSTEM HEX WRENCH
• 10705034196626: MONARCH SPINE SYSTEM ROD CLAMP
• 10705034196589: MONARCH SPINE SYSTEM ROD BENDERS (IN-SITU) SET 5.5mm
• 10705034196435: MONARCH SPINE SYSTEM MODULAR HEXLOBE DRIVER x15
• 10705034063096: MONARCH SPINE SYSTEM DUAL DIAMETER ROD 5.5/4.75 x 600mm
• 10705034063089: MONARCH SPINE SYSTEM DUAL DIAMETER ROD 5.5/4.75 x 450mm
• 10705034063065: MONARCH SPINE SYSTEM END TO END DUAL CONNECTOR 5.5mm - 4.75mm
• 10705034063058: MONARCH SPINE SYSTEM END TO END DUAL CONNECTOR 5.5mm - 5.5mm
• 10705034063041: MONARCH SPINE SYSTEM DUAL CONNECTOR, CLOSED, SIDE 5.5mm - 4.75mm
• 10705034063034: MONARCH SPINE SYSTEM SIDE BY SIDE DUAL CONNECTOR 5.5mm - 4.75mm
• 10705034063027: MONARCH SPINE SYSTEM DUAL CONNECTOR, CLOSED, SIDE 5.5 - 5.5mm
• 10705034063010: MONARCH SPINE SYSTEM SIDE BY SIDE DUAL CONNECTOR 5.5 - 5.5mm
• 10705034062846: MONARCH SPINE SYSTEM CLOSED HOOK - NARROW 5.5 x 11mm
• 10705034062839: MONARCH SPINE SYSTEM CLOSED HOOK - NARROW 5.5 x 9.5mm
• 10705034062822: MONARCH SPINE SYSTEM CLOSED HOOK - NARROW 5.5 x 8.0mm
• 10705034062815: MONARCH SPINE SYSTEM CLOSED HOOK - NARROW 5.5 x 6.5mm
• 10705034062808: MONARCH SPINE SYSTEM CLOSED HOOK - NARROW 5.5 x 5mm
• 10705034062785: MONARCH SPINE SYSTEM CLOSED HOOK-WIDE 5.5 x 11mm
• 10705034062778: MONARCH SPINE SYSTEM CLOSED HOOK-WIDE 5.5 x 9.5mm
• 10705034062761: MONARCH SPINE SYSTEM CLOSED HOOK-WIDE 5.5 x 8mm
• 10705034062754: MONARCH SPINE SYSTEM CLOSED HOOK-WIDE 5.5 x 6.5mm
• 10705034062747: MONARCH SPINE SYSTEM CLOSED HOOK-WIDE 5.5 x 5mm
• 10705034062532: MONARCH SPINE SYSTEM ROD 5.5 x 600mm
• 10705034061887: MONARCH SPINE SYSTEM ROD WITH VHG BODY 5.5 125mm
• 10705034061870: MONARCH SPINE SYSTEM TRANSVERSE ROD CONNECTOR 5.5 - 5.5mm
• 10705034061863: MONARCH SPINE SYSTEM ROD WITH VHG BODY 5.5 60mm
• 10705034061856: MONARCH SPINE SYSTEM ROD WITH VHG BODY 5.5 40mm
• 10705034062396: MONARCH SPINE SYSTEM SLOTTED CONNECTOR WITH WASHER, OFFSET, LEFT 5.5mm
• 10705034062372: MONARCH SPINE SYSTEM SLOTTED CONNECTOR WITH WASHER, OFFSET, RIGHT 5.5mm
• 10705034062365: MONARCH SPINE SYSTEM S/C WITH WASHER, EXT 5.5mm
• 10705034062358: MONARCH SPINE SYSTEM S/C WITH WASHER, STRAIGHT 5.5mm