SentioMMG 2010

GUDID 00853926005051

SentioMMG Control Unit

INNOVATIVE SURGICAL SOLUTIONS LLC

Nerve-locating system, line-powered

• Primary Device ID: 00853926005051
• NIH Device Record Key: 8edf8926-8ca4-4834-bf06-0ade15c1bbdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SentioMMG
• Version Model Number: 2010
• Catalog Number: 2010
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853926005051 [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