T-Lite

GUDID 03701104600154

Single Crystal Convex Probe 1.5-6Mhz

SONOSCANNER

Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 03701104600154
• NIH Device Record Key: 31c4b0e6-e777-4f5f-bb74-5a6cdbc7e643
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-Lite
• Version Model Number: PR59
• Company DUNS: 267799927
• Company Name: SONOSCANNER
• 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: 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	03701104600154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201988

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-30
• Device Publish Date: 2020-11-20

On-Brand Devices [T-Lite]

• 03701104600161: Hockey Stick Probe 10-18Mhz
• 03701104600154: Single Crystal Convex Probe 1.5-6Mhz
• 03701104600147: MicroConvex Probe R15 4-9Mhz
• 03701104600130: Linear Access Probe 5-12.5 Mhz
• 03701104600123: Convex Access probe 2-5Mhz
• 03701104600116: Handheld Ultrasound Scanner T-Lite with exchangeable probes