Footctrl 1600631-001

GUDID J00716006310011

Surgical power tool system control unit, line-powered

Primary Device ID	J00716006310011
NIH Device Record Key	9766041f-60ad-4e5d-b5c1-60195928704e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Footctrl
Version Model Number	1600631-001
Catalog Number	1600631-001
Company DUNS	480082080
Company Name	Bien-Air Dental SA
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	J00716006310011 [Primary]

EBW	Controller, foot, handpiece and cord

Steralize Prior To Use	false
Device Is Sterile	false

J00716014080011 - PM CA 20:1 L RO 104936	2024-12-06 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele
J00716014090011 - PM PM 1:1 RO sp. ext. 104936	2024-12-06 Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an ele
J00716012420011 - XPU MMOTOR LIGHT	2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic
J00716012450011 - I-SURGER LED	2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic
J00716012470011 - LIGHT MOTOR	2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic
J00717008000011 - SET STUDENTS BAUSA 8	2024-01-31 SET of different CA & HP supplied for students.
J00717008170011 - SET OPTIMA MX2 EDUCATIONAL 6	2024-01-31 Optima consoles are standard tabletop consoles integrating a Bien-Air Dental SA's board connected to a dental pneumatic unit.
J00717008420011 - SET STUDENTS BAUSA 13	2024-01-31 SET of different CA & HP supplied for students.