Stern Weber

Basic Information

• Brand Name: Stern Weber
• Primary DI: 08033837933700
• Version / Model: S210 LR ORTHO
• Catalog Number: 71YGXXXX
• Company Name: CEFLA SOCIETA' COOPERATIVA
• Labeler DUNS: 429341410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-08
• Public Version: 1
• Public Version Date: 2021-11-16
• Public Version Status: New
• Public Device Record Key: 422783d5-814c-467b-bb9e-c65b1d41cd4f

Device Description

The device is a dental unit consisting of components and/or devices that are functionally connected, such as the patient dental chair, dental unit, dental handpieces, multifunction pedal and operating light. This is a dental unit with ambidextrous hydric unit, in which the dental chair is placed on the floor, while the hydric unit is solidly attached to the chair and can be oriented to the right or to the left of the chair. This device is in "ORTHO" version: it is not provided with a dentist table, which is replaced by a tray; the instruments are on the assistant's board, which is mounted on a double-articulated tubular arm. The last four characters "XXXX" of the catalog number can be different alphanumeric characters.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELC	Scaler, Ultrasonic	Dental	872.4850	2
EIA	Unit, Operative Dental	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34991	Dental delivery system	A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08033837933700	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -10 – 70 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity