301019034

GUDID 10705034561370

NAVIGATION ENABLED INSTRUMENTS CORTICAL FIX THREAD TAP 5.0MM

Medos International Sàrl

Bone tap, reusable

• Primary Device ID: 10705034561370
• NIH Device Record Key: 468d9c8d-d607-4daf-85f0-02b87fea07d4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3010-19-034
• Catalog Number: 301019034
• 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
• 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	10705034561370 [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

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

[10705034561370]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-03
• Device Publish Date: 2021-04-24

Devices Manufactured by Medos International Sàrl

• 10705034194783 - PROFILE: 2025-06-25 PROFILE ANTERIOR FIXATION SYSTEM CALIPER
• 10705034604534 - TELIGEN: 2025-06-12 TELIGEN REDUCED ACCESS WITH SOFT TISSUE RETRACTOR
• 10705034604541 - TELIGEN: 2025-06-12 TELIGEN REDUCED ACCESS
• 10886705001163 - VERSALOK: 2025-05-08 Versalok Anchor with Threader Tab
• 10886705032952 - GRYPHON X: 2025-04-30 GRYPHON X PUSH-IN BR Anchor w/ DYNACORD and Needles
• 10886705032969 - GRYPHON X: 2025-04-30 GRYPHON X PUSH-IN BR Anchor_x000D_ w/ Dual Strand DYNACORD and Needles
• 10886705032976 - GRYPHON X: 2025-04-30 GRYPHON X THREADED BR Anchor_x000D_ w/ DYNACORD and Needles
• 10886705032983 - GRYPHON X: 2025-04-30 GRYPHON X THREADED BR Anchor _x000D_ w/ Dual Strand DYNACORD and Needles