MONARCH 177496450

GUDID 10705034063102

MONARCH SPINE SYSTEM DUAL DIAMETER ROD 5.5/6.35 x 450mm

Medos International Sàrl

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10705034063102
• NIH Device Record Key: bbfb19d4-6272-4671-adbf-789c2dbd0c6f
• Commercial Distribution Discontinuation: 2019-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONARCH
• Version Model Number: 177496450
• Catalog Number: 177496450
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034063102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024348

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[10705034063102]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-12
• Device Publish Date: 2015-09-24

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