AccessGUDID - DEVICE: Castellini (08033837932789)

GUDID

Device Identifier (DI) Information

Brand Name: Castellini
Version or Model: handy POWER LED
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 95520667
Company Name: CEFLA SOCIETA' COOPERATIVA

Primary DI Number: 08033837932789
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429341410 *Terms of Use

Device Description: The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear-reducing, or gear increasing speed. They are intended for professional use in dental surgery such as: preventive dentistry, restorative applications, endodontic treatment, prosthetic applications and implantology practices.

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?
66227	Dental surgical power tool motor, electric	A hand-held, electrically-powered component of a dental power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy for drilling or sawing during dental surgery. It is designed to accept handpiece components/attachments (not included) and is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It might be operated with a hand- or foot-switch. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBW	Controller, Foot, Handpiece And Cord

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213022	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 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: ce1b6097-6955-4b17-9bd7-a96f5480878f
Public Version Date: September 27, 2023
Public Version Number: 3
DI Record Publish Date: June 01, 2022