AccessGUDID - DEVICE: HOSE MCX GREY (SPECIAL LENGTH) (J007160075601)

GUDID

Device Identifier (DI) Information

Brand Name: HOSE MCX GREY (SPECIAL LENGTH)
Version or Model: 1600756-0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1600756-0
Company Name: Bien-Air Dental SA

Primary DI Number: J007160075601
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480082080 *Terms of Use

Device Description: Hoses and couplings are essential accessories meant to connect micro-motors to the console or other boards, thus allowing the control and functioning of the whole device.

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?
45121	Pneumatic dental handpiece coupler	A short connecting device intended to couple a pneumatic dental handpiece (e.g., a dental high-speed drill handpiece, dental restorative material sonic handpiece) and the hose that connects to the dental delivery system or a control unit, to provide the operator full rotational freedom of movement of the handpiece. This device contains a swivel mechanism that allows the freedom of movement. 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: a7954309-9815-4924-8300-722731b9d21b
Public Version Date: July 29, 2021
Public Version Number: 1
DI Record Publish Date: July 21, 2021