AccessGUDID - DEVICE: Castellini (08033837933908)

GUDID

Device Identifier (DI) Information

Brand Name: Castellini
Version or Model: PUMA ELI A R M CP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 71LEXXXX
Company Name: CEFLA SOCIETA' COOPERATIVA

Primary DI Number: 08033837933908
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429341410 *Terms of Use

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 MODULAR version ("M"): the hydric unit is not present, the assistant's board is connected to the back of the chair, and the lamp (optional) is installed under the dental chair. The last four characters "XXXX" of the catalog number can be different alphanumeric characters.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELC	Scaler, Ultrasonic
EIA	Unit, Operative Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 70 Degrees Celsius
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 50863732-ac1e-4f4d-8885-2dfac985114f
Public Version Date: November 16, 2021
Public Version Number: 1
DI Record Publish Date: November 08, 2021