Extender Cable, Autolith Touch/Uro-Touch

GUDID 00817183020028

Extender cable for use with Autolith Touch and Autolith Uro-Touch Lithotripters

NORTHGATE TECHNOLOGIES INC.

Electrohydraulic lithotripsy system

• Primary Device ID: 00817183020028
• NIH Device Record Key: 891cf912-f157-44af-a135-eb169443e0c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extender Cable, Autolith Touch/Uro-Touch
• Version Model Number: 9-004-00
• Company DUNS: 627969264
• Company Name: NORTHGATE TECHNOLOGIES INC.
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817183020028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130368

FDA Product Code

• FFK: Lithotriptor, Electro-Hydraulic

Sterilization

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

[00817183020028]

Moist Heat or Steam Sterilization

[00817183020028]

Moist Heat or Steam Sterilization

[00817183020028]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-13

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