ClariTEE CLT-010

GUDID 00861589000108

TEE ultrasound probe, single use, EO Sterile

IMACOR INC

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 00861589000108
• NIH Device Record Key: 6444b94a-6e60-4fcf-bcfd-36aa03451f6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClariTEE
• Version Model Number: ClariTEE
• Catalog Number: CLT-010
• Company DUNS: 604116553
• Company Name: IMACOR INC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 516 393 0970
• Email: jkujawski@Imacorinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861589000108 [Primary]
GS1	20861589000102 [Package]; Package: Box [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142054

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-12-21
• Device Publish Date: 2016-12-10

Devices Manufactured by IMACOR INC

• 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: 2018-12-21TEE ultrasound probe, single use, EO Sterile
• 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