286005324N

GUDID 10705034548876

Up Angled Curette Navigated 4mm

Medos International Sàrl

Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable Bone curette, reusable

• Primary Device ID: 10705034548876
• NIH Device Record Key: b8d53d99-e28d-40b8-a294-8f88d03904a8
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 286005324N
• Catalog Number: 286005324N
• 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	10705034548876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212756

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

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