289215116

GUDID 10705034564159

ATP/Lateral Discectomy Instruments Lateral Cobb Elevator Left, Navigable 12 degree ATP 12.7mm

Medos International Sàrl

Bone lever/elevator, reusable

• Primary Device ID: 10705034564159
• NIH Device Record Key: 22b39e85-3e9b-41a7-b67d-7868b57a8dbf
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 289215116
• Catalog Number: 289215116
• 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	10705034564159 [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

[10705034564159]

Moist Heat or Steam Sterilization

[10705034564159]

Moist Heat or Steam Sterilization

[10705034564159]

Moist Heat or Steam Sterilization

[10705034564159]

Moist Heat or Steam Sterilization

[10705034564159]

Moist Heat or Steam Sterilization

[10705034564159]

Moist Heat or Steam Sterilization

[10705034564159]

Moist Heat or Steam Sterilization

[10705034564159]

Moist Heat or Steam Sterilization

[10705034564159]

Moist Heat or Steam Sterilization

[10705034564159]

Moist Heat or Steam Sterilization

[10705034564159]

Moist Heat or Steam Sterilization

[10705034564159]

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

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• 10705034595542 - TRIALTIS: 2024-08-26 TRIALTIS Spine System Set Screw 4 Pack T27 5.5 and 6.0
• 10705034595887 - TRIALTIS: 2024-08-26 TRIALTIS Spine System Set Screw 8 Pack T27 5.5 and 6.0
• 10705034596891 - TRIALTIS: 2024-08-26 TRIALTIS Spine System Set Screw 2 Pack T27 5.5 and 6.0
• 10705034596907 - TRIALTIS: 2024-08-26 TRIALTIS Spine System Set Screw 6 Pack T27 5.5 and 6.0
• 10705034199504 - VIPER: 2024-08-20 VIPER SYSTEM CANNULA PLUNGER
• 10705034062358 - MONARCH: 2024-07-29 MONARCH SPINE SYSTEM S/C WITH WASHER, STRAIGHT 5.5mm