SENTIO 286202108

GUDID 20705034534753

SENTIO MMG SENSORS 8 PACK WITH GROUND

Medos International Sàrl

Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode

• Primary Device ID: 20705034534753
• NIH Device Record Key: 0ca4fec8-7a90-49bf-95e9-b8e2d65bd2c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SENTIO
• Version Model Number: 286202108
• Catalog Number: 286202108
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 8
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034534756 [Unit of Use]
GS1	20705034534753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173526

FDA Product Code

• PDQ: Neurosurgical nerve locator

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: 2018-11-08
• Device Publish Date: 2018-10-08

On-Brand Devices [SENTIO]

• 20705034534753: SENTIO MMG SENSORS 8 PACK WITH GROUND
• 20705034534746: SENTIO MMG SENSORS 4 PACK WITH GROUND
• 20705034534739: SENTIO MMG SENSORS 2 PACK WITH GROUND
• 10705034534824: SENTIO MMG JAMSHIDI TROCAR 6 INCH 11 GAUGE
• 10705034534817: SENTIO MMG JAMSHIDI BEVELED 6 INCH 11 GAUGE
• 10705034534763: SENTIO MMG BALL TIP ADJUSTABLE PROBE
• 10705034560366: SENTIO MMG STIMULATION WIRE