Autolith Touch

GUDID 00817183020004

Lithotripter

NORTHGATE TECHNOLOGIES INC.

Electrohydraulic lithotripsy system

• Primary Device ID: 00817183020004
• NIH Device Record Key: 681060fc-ecb7-4bf9-92bf-ab5d88be69ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Autolith Touch
• Version Model Number: 9-202-00
• 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: 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	00817183020004 [Primary]
GS1	00817183020042 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130368

FDA Product Code

• FFK: Lithotriptor, Electro-Hydraulic

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: 2016-09-26

On-Brand Devices [Autolith Touch]

• 00817183020561: Lithotripter, Biliary, BSC, Zero Cost Refurbished
• 00817183020554: Lithotripter, Biliary, BSC, Hospital Owned
• 00817183020547: Lithotripter, Biliary, BSC, Loaner
• 00817183020530: Lithotripter, Biliary, BSC, Demo
• 00817183020523: Lithotripter, Biliary, BSC, Refurbished
• 00817183020493: Lithotripter, Biliary, BSC
• 00817183020004: Lithotripter