ImaCor

GUDID 00861589000139

IMACOR INC

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 00861589000139
• NIH Device Record Key: 9f6ffb1b-76ca-4c3c-9922-24016e6afb39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImaCor
• Version Model Number: ZHH
• Company DUNS: 604116553
• Company Name: IMACOR INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861589000139 [Primary]

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

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: 2022-09-16
• Device Publish Date: 2022-09-08

Devices Manufactured by IMACOR INC

• 00861589000139 - ImaCor: 2022-09-16
• 00861589000139 - ImaCor: 2022-09-16
• 00861589000115 - ImaCor Inc.: 2020-05-13 Ultrasound Machine for use with ClariTEE probe
• 00861589000207 - ImaCor Inc.: 2020-01-27 Ultrasound Machine for use with ClariTEE probe
• 00861589000108 - ClariTEE: 2018-12-21 TEE ultrasound probe, single use, EO Sterile
• 00086158900201 - ImaCor Inc.: 2018-12-21 Ultrasound Machine for use with ClariTEE probe