Eu Mdd Eu Md Class 2a On The Market 🇺🇸 United States

Mr. Thirsty® One-Step Small Adult (100pk)

Zirc Dental Products Inc. · 🇺🇸 United States
Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1

Basic Information

Primary DI
00840161304896
Basic UDI-DI Code
B-00840161304896
Reference
50Z986SM-B
Device Types
Single use
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market

Additional Description

Product device description: The Mr. Thirsty® is a device comprised of two components which together create a device that connects to a high-volume evacuation Isolation System device that is used during dental procedures. The components consist of an angle tube which is made of polystyrene and a tongue shield that is made of a thermoplastic elastomer. The tongue shield component has a bite block designed into it. Intended use of the product: The Mr. Thirsty® device is intended for use with high volume evacuation for evacuation of fluids from the oral cavity. While also retracting the tongue and cheek of the patient during dental procedures in which sterile devices are not required. (Mr. Thirsty is not a sterile device). It assists the dental professional during dental procedures. During the procedure: the bite block props the patient’s mouth open, the tongue shield retracts both the tongue and cheek of the patient out of the working area, and the High-Volume Evacuator (HVE) it assists in keeping the working area dry by suctioning fluids and debris away and out of the oral cavity.

CND Nomenclature Codes

Code Description
Q019001 SALIVA ASPIRATORS AND SALIVA ABSORBENTS

Certificates

Type Number
MDD Annex II (excluding section 4) 41377454

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇾 Cyprus 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇸🇪 Sweden 🇸🇮 Slovenia 🇸🇰 Slovakia 🇹🇷 Türkiye 🇬🇧 United Kingdom

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