Lithotripsy Probe 9FR 54cm

GUDID 10817183020179

9FR 54cm Lithotripsy Probe for use with Autolith Lithotripters

NORTHGATE TECHNOLOGIES INC.

Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use

• Primary Device ID: 10817183020179
• NIH Device Record Key: fc64fbcd-2ddb-4e0c-9901-43ba44b5ee12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lithotripsy Probe 9FR 54cm
• Version Model Number: 9-900-54
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817183020172 [Primary]
GS1	10817183020179 [Package]; Contains: 00817183020172; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914516

FDA Product Code

• FFK: Lithotriptor, Electro-Hydraulic

Sterilization

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

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

On-Brand Devices [Lithotripsy Probe 9FR 54cm]

• 10817183020179: 9FR 54cm Lithotripsy Probe for use with Autolith Lithotripters
• 00817183020110: 9FR 54cm Lithotripsy Probe for use with Autolith Uro-Touch Lithotripters