| Primary Device ID | J00716012460011 |
| NIH Device Record Key | d73971ce-d72c-4d46-b856-4bc350492c3b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CABLE I-SURGE LED |
| Version Model Number | 1601246-001 |
| Company DUNS | 338234588 |
| Company Name | BIEN-AIR PORTUGAL, UNIPESSOAL, LDA |
| 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 |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com | |
| Phone | +1 949-477-6050 |
| ba-usa@bienair.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J00716012460011 [Primary] |
| EBW | Controller, Foot, Handpiece And Cord |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[J00716012460011]
Moist Heat or Steam Sterilization
[J00716012460011]
Moist Heat or Steam Sterilization
[J00716012460011]
Moist Heat or Steam Sterilization
[J00716012460011]
Moist Heat or Steam Sterilization
[J00716012460011]
Moist Heat or Steam Sterilization
[J00716012460011]
Moist Heat or Steam Sterilization
[J00716012460011]
Moist Heat or Steam Sterilization
[J00716012460011]
Moist Heat or Steam Sterilization
[J00716012460011]
Moist Heat or Steam Sterilization
[J00716012460011]
Moist Heat or Steam Sterilization
[J00716012460011]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-02 |
| Device Publish Date | 2024-04-24 |
| J00716012430011 - XPU MMOTOR CABLE | 2024-05-03 The cables deliver electrical power only. Since they are not equipped with water connection, cables include a shield wire for mo |
| J00716012480011 - HOSE LIGHT MOTOR | 2024-05-03 The hoses, also called “tuyaux” (“TY”), are accessories used to connect the micromotor to a dental unit or to a table-to |
| J00716012440011 - XPU MMOTOR NO LIGHT | 2024-05-02 The ELECTRIC MICROMOTORS transforms an electrical power into mechanical rotation movement, to define speed and torque to a dedic |
| J00716012460011 - CABLE I-SURGE LED | 2024-05-02The cables deliver electrical power only. Since they are not equipped with water connection, cables include a shield wire for motor grounding. |
| J00716012460011 - CABLE I-SURGE LED | 2024-05-02 The cables deliver electrical power only. Since they are not equipped with water connection, cables include a shield wire for mo |
| J007160080901 - TY MX2 400° calotte Ø20.2x40 | 2023-12-21 Hoses and couplings are essential accessories meant to connect micro-motors to the console or other boards, thus allowing the co |