SENTIO 286202200

GUDID 10705034534763

SENTIO MMG BALL TIP ADJUSTABLE PROBE

Medos International Sàrl

Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use Nerve-locating system probe, single-use

• Primary Device ID: 10705034534763
• NIH Device Record Key: 6e5fe30f-1644-465a-ba86-8fdc3e8ff496
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SENTIO
• Version Model Number: 286202200
• Catalog Number: 286202200
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034534763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173526

FDA Product Code

• ETN: STIMULATOR, NERVE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-09-20
• 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