301019027

GUDID 10705034561219

NAVIGATION ENABLED INSTRUMENTS DUAL LEAD AWL TIP TAP 10MM

Medos International Sàrl

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• Primary Device ID: 10705034561219
• NIH Device Record Key: c39e143d-fd87-4c40-86b8-e1a159a855f6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3010-19-027
• Catalog Number: 301019027
• 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
• 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
• 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	10705034561219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200791

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

[10705034561219]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-29
• Device Publish Date: 2020-10-21

Devices Manufactured by Medos International Sàrl

• 10705034507811 - VIPER PRIME: 2024-04-11 VIPER PRIME STYLET
• 10705034507828 - VIPER PRIME: 2024-04-11 VIPER PRIME NAVIGATION STYLET
• 10886705012367 - COR: 2024-03-27 COR Disposable Kit, 6mm
• 10886705012374 - COR: 2024-03-27 COR Disposable Kit, 8mm
• 10886705012381 - COR: 2024-03-27 COR Disposable Kit, 10mm
• 10886705012404 - COR: 2024-03-27 COR Disposable Kit, 8mm w/Perpendicularity
• 10886705012398 - COR: 2024-03-18 COR Disposable Kit, 6mm w/Perpendicularity
• 10886705012411 - COR: 2024-03-18 COR Disposable Kit, 10mm w/Perpendicularity