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ClariTEE

FDA UDI

Class II (US FDA UDI)

by Imacor, Inc.

Identity

Trade Name
ClariTEE FDA UDI
Generic Name
Hand-held ultrasound imaging system, body-surface FDA UDI
Device Name
TEE ultrasound probe, single use, EO Sterile FDA UDI
Model / Reference
ClariTEE FDA UDI
Description
TEE ultrasound probe, single use, EO Sterile FDA UDI

Identifiers

Catalog Number
CLT-010 FDA UDI
Primary DI / UDI-DI
00861589000108 FDA UDI
510(k) Number
K142054 FDA UDI
FDA Product Code
ITX FDA UDI
GMDN Term
Hand-held ultrasound imaging system, body-surface FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Hand-held ultrasound imaging system, body-surface

ClariTEE by Imacor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand-held ultrasound imaging system, body-surface.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Imacor, Inc.

Sources (1)

  • FDA UDI 6444b94a-6e60-4fcf-bcfd-36aa03451f6c 36 fields · synced May 30, 2026