Hose MX2 400 Grey

Basic Information

• Brand Name: Hose MX2 400 Grey
• Primary DI: J00716007000011
• Version / Model: 1600700-001
• Catalog Number: 1600700-001
• Company Name: BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
• Labeler DUNS: 338234588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-17
• Public Version: 2
• Public Version Date: 2022-10-26
• Public Version Status: Update
• Public Device Record Key: f1a4efc0-3f42-4d6c-9528-4b7510d3a91d

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EFB	Handpiece, air-powered, dental	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J00716007000011	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]