286755005N

GUDID 10705034515809

UNIVERSAL NAVIGATION BRAINLAB ADAPTOR

Medos International Sàrl

Orthopaedic implant-instrument extension adaptor, reusable

• Primary Device ID: 10705034515809
• NIH Device Record Key: dbec1ac2-22d1-4071-a8b1-38fb9b541ba7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 286755005N
• Catalog Number: 286755005N
• 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: 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)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	10705034515809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140927

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[10705034515809]

Moist Heat or Steam Sterilization

[10705034515809]

Moist Heat or Steam Sterilization

[10705034515809]

Moist Heat or Steam Sterilization

[10705034515809]

Moist Heat or Steam Sterilization

[10705034515809]

Moist Heat or Steam Sterilization

[10705034515809]

Moist Heat or Steam Sterilization

[10705034515809]

Moist Heat or Steam Sterilization

[10705034515809]

Moist Heat or Steam Sterilization

[10705034515809]

Moist Heat or Steam Sterilization

[10705034515809]

Moist Heat or Steam Sterilization

[10705034515809]

Moist Heat or Steam Sterilization

[10705034515809]

Moist Heat or Steam Sterilization

[10705034515809]

Moist Heat or Steam Sterilization

[10705034515809]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-03
• Device Publish Date: 2017-07-05

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• 10705034199504 - VIPER: 2024-08-20 VIPER SYSTEM CANNULA PLUNGER
• 10705034062358 - MONARCH: 2024-07-29 MONARCH SPINE SYSTEM S/C WITH WASHER, STRAIGHT 5.5mm
• 10705034062365 - MONARCH: 2024-07-29 MONARCH SPINE SYSTEM S/C WITH WASHER, EXT 5.5mm
• 10705034062372 - MONARCH: 2024-07-29 MONARCH SPINE SYSTEM SLOTTED CONNECTOR WITH WASHER, OFFSET, RIGHT 5.5mm