TruClear

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: TruClear FDA UDI
Generic Name: Hysteroscopic irrigation/insufflation system FDA UDI
Device Name: Calibration Insert FDA UDI
Model / Reference: 72203606 FDA UDI
Description: Calibration Insert FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521744141 FDA UDI
510(k) Number: K013870 FDA UDI
FDA Product Code: HIH FDA UDI
GMDN Term: Hysteroscopic irrigation/insufflation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 4.0 Millimeter FDA UDI

Category: Hysteroscopic irrigation/insufflation system

TruClear by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hysteroscopic irrigation/insufflation system.

Fluid Monitoring Unit — W.O.M. World of Medicine GmbH · Class II
Hayden Medical — Hayden Medical Inc · Class II
HysteroBalance II — W.O.M. World of Medicine GmbH · Class II
Fluid Safe — Stryker Corp. · Class II
TRUCLEARTM Calibration Insert 2.9 — Smith & Nephew, Inc. · Class II
Aquilex® Fluid Control System — W.O.M. World of Medicine GmbH · Class II
Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II
Premier — PREMIER DENTAL PRODUCTS COMPANY · Class II

Cleared under the same submission

K013870 also covers:

TruClear — Covidien LP

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Covidien LP

Sources (1)

FDA UDI 0de21ea9-c22d-4dcb-80e3-8a34e39b8633 36 fields · synced Jun 1, 2026