N/A 302015100

GUDID 10705034536217

UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION ARRAY VIOLET 4 SPHERES

Medos International Sàrl

Optical surgical navigation device tracking system spatial register, reusable

• Primary Device ID: 10705034536217
• NIH Device Record Key: 60212cd9-7743-421b-afb8-1040c5dd1b56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 302015100
• Catalog Number: 302015100
• 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034536217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201661

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

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[10705034536217]

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[10705034536217]

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[10705034536217]

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[10705034536217]

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[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

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[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

[10705034536217]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-23
• Device Publish Date: 2021-04-15

On-Brand Devices [N/A]

• 10886704082385: Large Bore Catheter 0.085 in (2.16 mm) Minimum Guide Diameter Proximal OD: 0.0825 in / 2.10 mm D
• 10886704082378: Large Bore Catheter 0.085 in (2.16 mm) Minimum Guide Diameter Proximal OD: 0.0825 in / 2.10 mm D
• 10886704082361: Large Bore Catheter 0.085 in (2.16 mm) Minimum Guide Diameter Proximal OD: 0.0825 in / 2.10 mm D
• 10705034558158: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION RING diameter 12 - ST
• 10705034536224: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION ARRAY ORANGE 3 SPHERES
• 10705034536217: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION ARRAY VIOLET 4 SPHERES
• 10705034536200: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION ARRAY GREY 3 SPHERES
• 10705034536194: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION ARRAY YELLOW 3 SPHERES
• 10705034536187: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION ARRAY BLUE 3 SPHERES
• 10705034536156: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION RING diameter 12
• 10705034536170: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION RING diameter 22
• 10705034536163: UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION RING diameter 17
• 10705034581828: MODIFIED INSTRUMENT SCREWDRIVER
• 10705034581507: MODIFIED INSTRUMENT CANNULATED SHAFT
• 10705034581392: MODIFIED INSTRUMENT X25 TIGHTENER
• 10705034581385: MODIFIED INSTRUMENT RE-ATTACHING TOOL
• 10705034581378: MODIFIED INSTRUMENT FACILITATOR
• 10705034600260: Open Lateral Connector Adjustable, Flanged ø5.5-6mm to 6mm x 50mm
• 10705034600246: Open Lateral Connector Adjustable, Flanged ø5.5-6mm to 6mm x 30mm
• 10705034600147: Open Lateral Connector Adjustable ø5.5-6mm to 6mm x 50mm
• 10705034600130: Open Lateral Connector Adjustable ø5.5-6mm to 6mm x 30mm