Premier

FDA UDI

Class II (US FDA UDI)

by Premier Dental Products Company

Identity

Trade Name: Premier FDA UDI
Generic Name: Hysteroscopic irrigation/insufflation system FDA UDI
Device Name: CANNULA JARCHO SELF-RETAINING FDA UDI
Model / Reference: 1030840 FDA UDI
Description: CANNULA JARCHO SELF-RETAINING FDA UDI

Identifiers

Primary DI / UDI-DI: D6911030840 FDA UDI
FDA Product Code: HIG FDA UDI
GMDN Term: Hysteroscopic irrigation/insufflation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1700 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

Yes

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

Category: Hysteroscopic irrigation/insufflation system

Premier by Premier Dental Products Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Aquilex® Fluid Control System — W.O.M. World of Medicine GmbH · Class II
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ThermaClear — Stryker Corp. · Class II

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: Premier Dental Products Company

Sources (1)

FDA UDI ff5bcfeb-f6b3-4f34-9595-243999dce3fa 33 fields · synced May 30, 2026