CABLE I-SURGE LED

Basic Information

• Brand Name: CABLE I-SURGE LED
• Primary DI: J00716012460011
• Version / Model: 1601246-001
• 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: 2024-04-24
• Public Version: 2
• Public Version Date: 2026-02-11
• Public Version Status: Update
• Public Device Record Key: d73971ce-d72c-4d46-b856-4bc350492c3b

Device Description

The cables deliver electrical power only. Since they are not equipped with water connection, cables include a shield wire for motor grounding.

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
EBW	Controller, Foot, Handpiece And Cord	Dental	872.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66247	Dental power tool handpiece motorless component	A component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J00716012460011	HIBCC

Customer Contacts

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