IHX 6-25

GUDID 08056304455390

ESAOTE SPA

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 08056304455390
• NIH Device Record Key: 497f4360-b2d3-42ff-b084-9581e3c88b28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IHX 6-25
• Version Model Number: 120000137
• Company DUNS: 437384304
• Company Name: ESAOTE SPA
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056304455390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241671

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: 2025-07-15
• Device Publish Date: 2025-07-07

Devices Manufactured by ESAOTE SPA

• 08056304455826 - MyLabC25: 2025-12-18
• 08056304455833 - MyLabC30: 2025-12-18
• 08056304450296 - MyLabSix CrystallLine: 2025-12-15 Real Name MyLabSix CrystaLine
• 08056304452597 - MyLabSeven: 2025-12-15 Version V2
• 08056304452603 - MyLabEight eXP: 2025-12-15
• 08056304452610 - MyLabEight: 2025-12-15
• 08056304452658 - MyLab 9 eXP: 2025-12-15
• 08056304452917 - C 1-8: 2025-12-15