289215012

GUDID 10705034564197

ATP/Lateral Discectomy Instruments Lateral Cobb Elevator Angled Tip, Navigable Angled-Tip 12.7mm

Medos International Sàrl

Bone lever/elevator, reusable Bone lever/elevator, reusable Bone lever/elevator, reusable Bone lever/elevator, reusable Bone lever/elevator, reusable Bone lever/elevator, reusable Bone lever/elevator, reusable Bone lever/elevator, reusable Bone lever/elevator, reusable Bone lever/elevator, reusable Bone lever/elevator, reusable Bone lever/elevator, reusable

• Primary Device ID: 10705034564197
• NIH Device Record Key: 37cd7453-3e73-4f94-909c-171826716b98
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 289215012
• Catalog Number: 289215012
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034564197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212756

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[10705034564197]

Moist Heat or Steam Sterilization

[10705034564197]

Moist Heat or Steam Sterilization

[10705034564197]

Moist Heat or Steam Sterilization

[10705034564197]

Moist Heat or Steam Sterilization

[10705034564197]

Moist Heat or Steam Sterilization

[10705034564197]

Moist Heat or Steam Sterilization

[10705034564197]

Moist Heat or Steam Sterilization

[10705034564197]

Moist Heat or Steam Sterilization

[10705034564197]

Moist Heat or Steam Sterilization

[10705034564197]

Moist Heat or Steam Sterilization

[10705034564197]

Moist Heat or Steam Sterilization

[10705034564197]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-17
• Device Publish Date: 2022-08-09

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