Extender Cable, Autolith

GUDID 00817183020127

Extender cable for use with Autolith Lithotripters

NORTHGATE TECHNOLOGIES INC.

Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system Electrohydraulic lithotripsy system

• Primary Device ID: 00817183020127
• NIH Device Record Key: 74a5297b-ead7-4f08-ab6b-a1d9fb739b83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extender Cable, Autolith
• Version Model Number: 9-002-00
• 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	00817183020127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923822

FDA Product Code

• FFK: Lithotriptor, Electro-Hydraulic

Sterilization

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

[00817183020127]

Moist Heat or Steam Sterilization

[00817183020127]

Moist Heat or Steam Sterilization

[00817183020127]

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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