MyLabSigma

GUDID 08056304453679

ESAOTE SPA

General-purpose ultrasound imaging system

• Primary Device ID: 08056304453679
• NIH Device Record Key: 3e078599-0f97-4c02-893b-a9ff19143ae5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyLabSigma
• Version Model Number: 101741004
• 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	08056304453679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191072

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: 2019-06-21
• Device Publish Date: 2019-06-13

Devices Manufactured by ESAOTE SPA

• 08056304450852 - MyLab30 Gold Cardiovascular: 2024-11-25
• 08056304450869 - MyLab25 Gold: 2024-11-25
• 08056304451880 - PA121E: 2024-11-25
• 08056304452191 - TE122: 2024-11-25 correct brand name is TEE122 with two E
• 08056304453419 - MyLabX8: 2024-11-25
• 08056304454126 - MyLabX8 eXP: 2024-11-25
• 08056304455727 - G-scan Open: 2024-07-10
• 08056304455741 - O-scan Smart: 2024-07-10