StimSite Activation Card

GUDID 00817183020776

Activation Card, StimSite, Single

NORTHGATE TECHNOLOGIES INC.

Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system

• Primary Device ID: 00817183020776
• NIH Device Record Key: f2ba28a9-6fb0-4bac-b9e3-1c77502dd013
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StimSite Activation Card
• Version Model Number: AM-2101
• Company DUNS: 627969264
• Company Name: NORTHGATE TECHNOLOGIES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	00817183020776 [Primary]
GS1	00860002926919 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200886

FDA Product Code

• ETN: Stimulator, Nerve

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: 2023-11-29
• Device Publish Date: 2023-11-21

Devices Manufactured by NORTHGATE TECHNOLOGIES INC.

• 00817183020776 - StimSite Activation Card: 2023-11-29Activation Card, StimSite, Single
• 00817183020776 - StimSite Activation Card: 2023-11-29 Activation Card, StimSite, Single
• 00817183020660 - NEBULAE SRS Tubing Set: 2023-02-22
• 00817183020684 - NEBULAE SRS Laparoscopic Surgical Pump: 2023-02-22
• 00817183020745 - Smith & Nephew Insufflator 500: 2021-01-14 Insufflator, Laparoscopic, S&N 500 Service Replacement, 50LPM
• 10817183020605 - TAP: 2021-01-13 Insufflation Tubing, True Abdominal Pressure Sensing
• 00817183020707 - N/A: 2021-01-13 Insufflation Tubing, General Use CPC
• 00817183020714 - N/A: 2021-01-13 CO2 Shuttle Valve System, Insufflation
• 00817183020721 - N/A: 2021-01-13 CO2 Hose and DISS, Insufflation