SentioMMG 2009

GUDID 00853926005044

MMG Sensor Kit of (2)

INNOVATIVE SURGICAL SOLUTIONS LLC

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: 00853926005044
• NIH Device Record Key: c4e9ab53-d792-4901-8bb1-d81638084998
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SentioMMG
• Version Model Number: 2009
• Catalog Number: 2009
• Company DUNS: 013197873
• Company Name: INNOVATIVE SURGICAL SOLUTIONS LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853926005044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131304

FDA Product Code

• PDQ: Neurosurgical Nerve Locator

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [SentioMMG]

• 00853926005068: SentioMMG Sensor Harness Ref 24A05
• 00853926005051: SentioMMG Control Unit
• 00853926005044: MMG Sensor Kit of (2)
• 00853926005037: MMG Sensor Kit of (8)
• 00853926005020: MMG Sensor Kit of (4)
• 00853926005013: Stimulation Sterile Disposables
• 00853926005006: Navigational Sterile Disposables