AccessGUDID - DEVICE: Set MC3 LED + Hose for Sirona (J00717004480011)

GUDID

Device Identifier (DI) Information

Brand Name: Set MC3 LED + Hose for Sirona
Version or Model: 1700448-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1700448-001
Company Name: BIEN-AIR PORTUGAL, UNIPESSOAL, LDA

Primary DI Number: J00717004480011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338234588 *Terms of Use

Device Description: Set of micromotor with hose

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?
40593	Pneumatic dental power tool hose	A single- or double-lumen (coaxial) tube in a straight or spiral design intended to be used to conduct compressed gas from a source to a dental drilling system handpiece to provide power to the turbine. The device is of an adequate length to provide manoeuvrability of the handpiece. The coaxial types have a double tube (inner and outer tubing) to facilitate the removal of the exhaust gases. This is a reusable device.	Active	false
38763	Remotely-driven dental drilling system motor	A mains electricity (AC-powered) compact motor used in conjunction with a spinning cable (e.g., a Bowden cable) to provide remote rotational power from the motor to a dental drill handpiece. This device is line-powered and cannot be sterilized. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EFB	Handpiece, air-powered, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ec45ab13-5947-4c2e-9c80-177450091700
Public Version Date: October 26, 2022
Public Version Number: 4
DI Record Publish Date: June 17, 2021