Castellini - The device is a dental unit consisting of - CEFLA SOCIETA' COOPERATIVA

Duns Number:429341410

Device Description: The device is a dental unit consisting of components and/or devices that are functionally 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.

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More Product Details

Catalog Number

71LEXXXX

Brand Name

Castellini

Version/Model Number

PUMA ELI A R M CP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EIA

Product Code Name

Unit, Operative Dental

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CEFLA SOCIETA' COOPERATIVA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 63