UreTron Flexible Sterile Probe

GUDID 00854732006294

UreTron 0.8 x 1370 mm Sterile Flexible Probe

MED-SONICS CORPORATION

Ultrasonic lithotripsy system reusable

• Primary Device ID: 00854732006294
• NIH Device Record Key: d05a2f4c-5a6e-4628-b0d6-d0eddcf003f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UreTron Flexible Sterile Probe
• Version Model Number: URT-PF-0.8-1370S
• Company DUNS: 009836084
• Company Name: MED-SONICS CORPORATION
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854732006294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162119

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: 2016-09-12

On-Brand Devices [UreTron Flexible Sterile Probe]

• 00854732006300: UreTron Sterile Flexible Probe 0.8 x 920 mm
• 00854732006294: UreTron 0.8 x 1370 mm Sterile Flexible Probe