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 dental unit, dental handpieces, multifunction pedal.The dentist board is mounted on a mobile cart equipped with wheels, mechanically separated from the rest of the dental unit but electrically connected to it.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.
Catalog Number
71LFXXXX
Brand Name
Castellini
Version/Model Number
PUMA ELI A R M CART
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
EIA
Product Code Name
Unit, Operative Dental
Public Device Record Key
9c16bdda-0725-49c4-995b-88b5f8eb2d99
Public Version Date
November 16, 2021
Public Version Number
1
DI Record Publish Date
November 08, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |