AccessGUDID - DEVICE: HOSE LIGHT MOTOR (J00716012480011)

GUDID

Device Identifier (DI) Information

Brand Name: HOSE LIGHT MOTOR
Version or Model: 1601248-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIEN-AIR PORTUGAL, UNIPESSOAL, LDA

Primary DI Number: J00716012480011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338234588 *Terms of Use

Device Description: The hoses, also called “tuyaux” (“TY”), are accessories used to connect the micromotor to a dental unit or to a table-top device. For all hoses, the main function is to deliver electrical power, air and water to the micromotor.

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

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: a5a0f25f-a3fa-41c4-9582-2711285d3477
Public Version Date: May 03, 2024
Public Version Number: 1
DI Record Publish Date: April 25, 2024