TRUCLEARTM Calibration Insert 4.0

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: TRUCLEARTM Calibration Insert 4.0 FDA UDI
Generic Name: Hysteroscopic irrigation/insufflation system FDA UDI
Device Name: TRUCLEAR CALIBRATION INSERT 4.0 FDA UDI
Model / Reference: 72203606 FDA UDI
Description: TRUCLEAR CALIBRATION INSERT 4.0 FDA UDI

Identifiers

Catalog Number: 72203606 FDA UDI
Primary DI / UDI-DI: 00885554027600 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Hysteroscopic irrigation/insufflation system

TRUCLEARTM Calibration Insert 4.0 by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Smith & Nephew, Inc.

Sources (1)

FDA UDI e480c487-faf6-4f3d-b211-d57f508a77a6 35 fields · synced Jun 8, 2026